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

Catalog Number PROC2

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Incontinence (1928); Itching Sensation (1943); Muscle Spasm(s) (1966); Pain (1994); Not Applicable (3189)

Event Date 11/08/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2011 and mesh was implanted.The patient experience painful intercourse, mild incontinence, pelvic pain, vaginal spasms, buttock pain, unexplained episodes of fainting, lichen sclerosus, itchy upper legs, vaginal polyp and urethral erosion.The mesh was partially removed in 2013 and more mesh is scheduled to be removed.No additional information is available.

• 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.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7001149
• MDR Text Key: 91055386
• Report Number: 2210968-2017-70797
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: PROC2
• Device Lot Number: 3540177
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/03/2017
• Date Device Manufactured: 06/01/2011
• 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