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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

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ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Insufficient Information (4580)
Event Date 03/17/2010
Event Type  Injury  
Event Description
It was reported that a patient underwent an anterior gynecological procedure on (b)(6) 2010 and the mesh was implanted. It was reported that the patient experienced pelvic pain, lower back pain, pain over buttocks and pubic bone, difficulty standing straight, and incomplete emptying of bladder.
 
Manufacturer Narrative
(b)(4). If further details are received at a later date a supplemental medwatch will be sent.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12728490
MDR Text Key284630464
Report Number2210968-2021-10663
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device?

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