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

Catalog Number MESHUNK

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

Patient Problem Not Applicable (3189)

Event Date 05/21/2018

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 additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure? product code and lot number implanted during initial procedure, sacrocolpopexy in 2005? will product be returned, return date and 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? the initial approach for the index surgical procedure ? any concurrent procedure/device implantation? were there any intra-operative complications? what were current symptoms following the index surgical procedure, sacrocolpopexy in 2005? onset date? what was a reason/indication for partial removal and bowel resection on (b)(6) 2018? when was the mesh erosion/exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? date - time of onset of infection from the initial surgical procedure in 2005? were cultures performed? results? what medical intervention was performed? results? what is physician¿s opinion as to the etiology of or contributing factors to the event on (b)(6) 2018? what is the patient's current status?.

Event Description

It was reported that the patient underwent a surgical procedure for vaginal vault prolapse/sacrocolpopexy in 2005 and the mesh was implanted.On (b)(6) 2018, the patient underwent a surgery for partial removal of mesh and small bowel resection.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.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8262418
• MDR Text Key: 133688499
• Report Number: 2210968-2019-78488
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• 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: 01/03/2019
• 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