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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMESH PS; MESH, SURGICAL
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ETHICON INC. GYNECARE GYNEMESH PS; MESH, SURGICAL Back to Search Results
Catalog Number GPSL34
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and an mesh was implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent a revision surgery on (b)(6) 2007.No additional information was provided.
 
Manufacturer Narrative
In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
Date sent to fda: 6/24/2019.
 
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Brand Name
GYNECARE GYNEMESH PS
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7303117
MDR Text Key101166089
Report Number2210968-2018-71043
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 other
Type of Report Initial,Followup,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2016
Device Catalogue NumberGPSL34
Device Lot NumberDCP836
Was Device Available for Evaluation? No
Date Manufacturer Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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