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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Burning Sensation (2146); 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 a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a gynecological procedure on an unknown date and mesh was implanted. Two years following the procedure, the patient presented with burning in the vagina. A few strands of exposed mesh were found in the right paraurethral sulcus and trimmed in clinic. Additional information will be requested.

Manufacturer Narrative

Additional information was requested and the following was received: the initial approach for the index surgical procedure? - 2016 the patient demographic info: age, weight, bmi at the time of index procedure - na any concurrent procedure/device implantation? - na were there any intra-operative complications? - na when was the mesh exposure first noted by a physician? -(b)(6) 2018 mesh exposure site/location, symptoms and diagnostic confirmation? - right paraurethral sulcus. Describe medical/surgical intervention for exposure including dates and findings - (b)(6) 2018 trimmed tape in clinic product code and lot # - na what is physician¿s opinion as to the etiology of or contributing factors to this event - na did the patient's condition improve after the device was completely removed? - na.

• 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 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7337535
• MDR Text Key: 102330586
• Report Number: 2210968-2018-71427
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 03/14/2018 Patient Sequence Number: 1