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

Catalog Number MESHUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)

Event Date 05/23/2019

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. The patient demographic info: age, weight, bmi at the time of index procedure date, diagnosis and name of initial surgical procedure, other relevant patient history/concomitant medications, product code and lot number? if applicable, will product be returned, return date, tracking information were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre, intra- or post-operation? onset date of pain from initial surgery? location? date - time of onset of infection from the surgical procedure? were cultures performed? results? when was the mesh exposure first noted by a physician? mesh exposure diagnostic confirmation? date and surgical findings of mesh removal/total excision procedure? was any deficiency or anomaly of the mesh? if yes, please describe it? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on unknown date and the mesh was implanted. After the procedure, the patient presented with chronic pain and infected post vaginal wall mesh exposure/infected mesh. The mesh total excision was performed surgically. The device quarantined in histopathology. Additional information has been requested.

• 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.; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8733360
• MDR Text Key: 149159273
• Report Number: 2210968-2019-83271
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: MESHUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/02/2019
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/26/2019 Patient Sequence Number: 1