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

Catalog Number MESHUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Not Applicable (3189)

Event Date 03/07/2019

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.Additional information was requested, and the following was obtained: no more feedback available.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? other relevant patient history/concomitant medications? product code and lot number? the initial approach for the index surgical procedure? any concurrent procedure or other device implantation? were there any intra-operative complications? when was the mesh exposure in both two areas first noted by a physician? mesh exposure diagnostic confirmation? what were surgical findings of mesh excision procedure? was any deficiency or anomaly of the mesh observed? if yes, please describe it.What is physician¿s opinion as to the etiology of or contributing factors to mesh exposure in two areas? what is the patient's current status?".

Event Description

It was reported that the patient underwent a gynecological procedure on unknown date and the mesh was implanted.The patient experienced mesh erosion in two small areas, one on posterior vaginal wall and one of anterior vaginal wall.The patient did not respond to vaginal oestrogen cream and a small amount of mesh was excised surgically.Exposed mesh was removed as day case surgical procedure.No further information is available.

• 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.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8528883
• MDR Text Key: 142406562
• Report Number: 2210968-2019-80498
• 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,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2019
• 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