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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFICBOSTON SCIENTIFIC - LYNXPUBOVAGINAL SLING

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BOSTON SCIENTIFIC BOSTON SCIENTIFIC - LYNX PUBOVAGINAL SLING   Back to Search Results
Model Number M0068503000
Event Date 11/07/2008
Event Type  Injury   Patient Outcome  Other,Disability,Required Intervention
Event Description

Pubovag sling surgery on (b)(6) 2008. (b)(4), lot = oml8072804. Use by = 2011 (b)(6). Continue to have incontinence problems and pain. Extreme pain with intercourse to the point that not able to have. The mental fear of the pain let alone the actual pain experienced are awful. Had a portion of the sling surgically removed on (b)(6) 2011. The surgeon noted that there was a slight erythema around the mid urethra. Did not remove any of the irritation tissue since the vagina was quite thin and atrophic in this area.

 
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Brand NameBOSTON SCIENTIFIC - LYNX
Type of DevicePUBOVAGINAL SLING
Manufacturer (Section F)
BOSTON SCIENTIFIC
Manufacturer (Section D)
BOSTON SCIENTIFIC
Device Event Key2425071
MDR Report Key2401028
Event Key2297864
Report NumberMW5023705
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/30/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/31/2011
Device MODEL NumberM0068503000
Device LOT NumberOML8072804
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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