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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.May we have a copy of operative report for mesh implant, revision and replacement surgeries in 2005, 2007 and 2008? the patient demographic info: age, weight, bmi at the time of index procedure 2005? other relevant patient comorbidities/concomitant medications? product code and lot number of the mesh implanted in surgery 2005? please provide date, indication and surgical findings of revision surgery for the mesh implanted in 2005? product code and lot number of the mesh implanted in surgery 2007? surgical findings of mesh replacement surgery in 2007? product code and lot number of the mesh implanted in surgery 2008? surgical findings of mesh replacement surgery in 2008? what is physician¿s opinion as to the etiology of or contributing factors to the recurrent bladder prolapse in 2007 and 2008? what is physician¿s opinion as to the etiology of or contributing factors to the events occurred after replacement surgery in 2008 (bleeding, bacterial infection, abscess and mesh erosion into vaginal walls)? what is the patient's current status? adverse events occurred after mesh #2 implanted in 2007 and mesh # 3 implanted in 2008 were captured in the related files and submitted via 2210968-2019-87966 and 2210968-2019-87970 medwatches accordingly.Please note: per fda, ¿we do not see the initial report number 2210968-2019-87949 in our system¿ and ¿ we cannot reprocess it from our end¿.Therefore, this medwatch is being submitted to resolve the issue.

Event Description

It was reported that the patient underwent a gynecological procedure in 2005 and the mesh was implanted.The mesh was unsuccessful.It was reported that a week or two after the surgery, the mesh ripped and the prolapse of bladder came back so the mesh had to be redone again.Exact date of revision surgery is unknown.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9623716
• MDR Text Key: 185968230
• Report Number: 2210968-2020-00642
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention