inforMED
OTMClass IIImplant

Mesh, Surgical, For Stress Urinary Incontinence, Male

General, Plastic Surgery · 21 CFR 878.3300

surgical treatment of male stress urinary incontinence post-prostatectomy

MDR events1,516All time
Recalls1All time
Registered firms17Currently listed
510(k) clearances12All time

Recent MDR events

1,516 adverse event reports on file

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Event type breakdown

Injury1,444
Malfunction64
Death6
Other2

Most-reported manufacturers

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Boston Scientific Corporation1,235American Medical Systems (mn)115Coloplast A/s78Boston Scientific - Minnetonka31American Medical Systems, Inc.28Mentor Worldwide Llc5Unspecified4A.m.i. Agency For Medical Innovations Gmbh4

Product problems

Reported product problem codes, most common first

Insufficient Device Problem Information1,052
Adverse Event Without Identified Device or Use Problem267
Mechanical Problem46
Defective Device28
Break23
Malposition of Device22
Device Operates Differently Than Expected14
Material Split, Cut or Torn10

Trend for “Insufficient Device Problem Information”

035Oct 23Mar 24Aug 24Jan 25Jun 25Nov 25Apr 26

Recalls

1 recall events for this product code

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Registered firms

17 firms currently registered for this product code

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510(k) clearances

12 clearances for this product code

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