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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Component code: (b)(4). 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. This file was reviewed by a cross functional team during the weekly ae review and the following questions were requested and assigned to bq via pcf: the patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? was the exposed mesh excised? describe any medical/surgical intervention for exposure and stones including dates and surgical findings. Product code and lot # what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.

Event Description

It was reported that a patient underwent a mesh-augmented vaginal repair on an unknown date in 2014 and the mesh was implanted. It was reported that the patient was diagnosed with bladder exposure of the mesh with bladder stones attached to the exposed mesh. It was also reported that the patient had cystoscopy and removal of the bladder stone with laser. It was also reported that the patient will have repeat cystoscopy in three to four months and will be referred to the regional mesh complication center. Additional information was requested.

• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12481763
• MDR Text Key: 271715441
• Report Number: 2210968-2021-08537
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2013
• 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: 09/16/2021 Patient Sequence Number: 1