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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
Lot Number XBP762
Device Problem Migration (4003)
Patient Problem Erosion (1750)
Event Date 03/29/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (b)(4). Device not returned. No additional information is available. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that a patient underwent an abdominal sacral hysteropexy on (b)(6) 2006 and the mesh was implanted. It was reported that the patient had mesh exposure excised on (b)(6) 2021.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11939969
MDR Text Key256089638
Report Number2210968-2021-05275
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2011
Device Lot NumberXBP762
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/04/2021 Patient Sequence Number: 1
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