inforMED
OTNClass IIImplant

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

General, Plastic Surgery · 21 CFR 878.3300

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

MDR events38,646All time
Recalls1All time
Registered firms86Currently listed
510(k) clearances65All time

Recent MDR events

38,646 adverse event reports on file

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Event type breakdown

Injury37,629
Malfunction607
Death376
Unspecified25
Other8
No answer provided1

Most-reported manufacturers

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Ethicon Inc.21,205Boston Scientific Corporation3,322Ethicon, Inc.3,110Sofradim Production1,948Ethicon Sarl1,488Boston Scientific - Marlborough999Unspecified968C.r. Bard, Inc. (covington) -1018233804

Recalls

1 recall events for this product code

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Registered firms

86 firms currently registered for this product code

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510(k) clearances

65 clearances for this product code

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