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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 Fistula (1862); Perforation (2001); Abnormal Vaginal Discharge (2123)
Event Date 10/05/2011
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent vh & colpopexy surgery on (b)(6) 2011 and mesh was implanted. It was reported the patient underwent a revision surgery on (b)(6) 2017 and a revision surgery on (b)(6) 2017. It was reported that the patient underwent a colonoscopy on (b)(6) 2021 during which the mesh was found with rectovaginal fistula condition. (part of the mesh was founded near rectum and it had a high possibility of perforation). It was the reported the patient experienced persistent discharge. No additional information was provided.
 
Manufacturer Narrative
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. (b)(4) submitted for adverse event which occurred on (b)(6) 2017. (b)(4) submitted for adverse event which occurred on (b)(6) 2017.
 
Manufacturer Narrative
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. (b)(4) submitted for adverse event which occurred on (b)(6) 2017. (b)(4) submitted for adverse event which occurred on (b)(6) 2017.
 
Event Description
It was reported by an attorney that the patient underwent vh & colpopexy surgery on (b)(6) 2011 and mesh was implanted. It was reported the patient underwent a revision surgery on (b)(6) 2017 and a revision surgery on (b)(6) 2017. It was reported that the patient underwent a colonoscopy on (b)(6) 2021 during which the mesh was found with rectovaginal fistula condition. (part of the mesh was founded near rectum and it had a high possibility of perforation). It was the reported the patient experienced persistent discharge. No additional information was provided.
 
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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 PR
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12775968
MDR Text Key285221126
Report Number2210968-2021-11070
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received10/25/2021
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: 11/08/2021 Patient Sequence Number: 1
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