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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ETHICON PMII PROLENE MESH 3X6 SHEETS

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ETHICON ETHICON PMII PROLENE MESH 3X6 SHEETS Back to Search Results
Model Number PMII
Event Date 11/25/2008
Event Type  Injury  
Event Description

Had pelvic organ prolapse and surgery in 2004 for pop. Doctor was awesome and did a great job; however, mesh implant rejected in 2008. Product was ethicon pmii prolene mesh 3x6 sheets. Surgery in 2008 to remove rejected mesh and clean infected tissue. Will likely have pop in near future since partial rejection the same month along with more rejection. The doctor said it would be highly probable for more rejection. Infection from rejected mesh made me very ill for one year as it took that long to discover infection was from rejected mesh.

 
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Brand NameETHICON PMII PROLENE MESH 3X6 SHEETS
Type of DevicePROLENE MESH
Manufacturer (Section D)
ETHICON
MDR Report Key1294044
Report NumberMW5009712
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/20/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPMII
Device LOT NumberTCB842 OR TCB892
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/20/2009 Patient Sequence Number: 1
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