Indications, safety, and warnings

Furlow Disposable Insertion Tool

Brief Summary Document — HCP

Product

Furlow Disposable Insertion Tool – IFU 51529131-01A

Rx statement

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

User Information
This device is to be used only by physicians who are trained in performing IPP surgical procedures.

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

Intended use/Indications for use

The Furlow Disposable Insertion Tool is a single-use manual surgical instrument intended to facilitate selection of the appropriate BSC IPP cylinder and insertion of the cylinder into the corpora cavernosa.

Contraindications

None known.

Warnings

Do not use this device in a manner which may cause tissue trauma.
Pre-existing penile or corporal scarring may make surgical use of the device complicated or impractical.
Failure to evaluate and promptly treat tunical trauma and perforations may result in a substantial worsening of the condition, and may lead to infection and/or loss of tissue.

Precautions

Refer to Furlow Disposable Insertion Tool Instructions for Use for all applicable information on Precautions.

Adverse events

Possible complications include, but may not be limited to:

Allergic reaction
Inflammation
Infection
Perforation
Tissue damage
Bleeding

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