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

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.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, 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 Key: 12775968
• MDR Text Key: 285221126
• Report Number: 2210968-2021-11070
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/08/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female