MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number GPSL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Fever (1858); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123)

Event Date 01/02/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on (b)(6) 2006 and the mesh was implanted.Following the procedure, the patient experienced erosion through vaginal wall, stomach pain, back pain, vaginal pain, pain in legs and groin area, vaginal discharge and urinary tract infections.The patient also experienced constant infections resistant to everyday antibiotics requiring hospital admission for iv antibiotics, constant low-grade fevers and excessive pain trying to have sexual intercourse.No further information is available.

• Brand Name: GYNECARE GYNEMESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6897151
• MDR Text Key: 87480030
• Report Number: 2210968-2017-70363
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Catalogue Number: GPSL
• Device Lot Number: XHR112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2017
• Date Device Manufactured: 07/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention