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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN

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ETHICON INC. GYNECARE MESH UNKNOWN Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further info 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 an undisclosed date and mesh was implanted. It was reported that she experienced undisclosed injuries. No additional information was provided.

 
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Brand NameGYNECARE MESH UNKNOWN
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-PENDING DETERMINATION
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5913875
MDR Text Key53479598
Report Number2210968-2016-11788
Device Sequence Number1
Product Code FTT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/30/2016 Patient Sequence Number: 1
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