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 Problems Fatigue (1849); Inflammation (1932); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Urinary Frequency (2275); Anxiety (2328); Depression (2361); Blood Loss (2597)

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.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on (b)(6) 2014 and the unknown mesh was implanted.Immediately post-surgery the patient experienced left leg pain.The surgeon opined that it was not associated with "surgeon".Post- recovery, the patient developed a vaginal scar tissue from incision and pain during sex.The patient also experienced difficulty laying on pubic bone, sharp sensation in pubic area from anchors and the development of other symptoms over time included lichen sclerosis, very painful, splitting and bleeding in vulva and clitoris, also adding to pain during urination, pain during intercourse and loss of pleasure.She experienced a joint pain, inflammation, nerve burning pain, groin pain worse at night and increased with full bladder or bowel, and disturbed sleep during the night due to urinary frequency required to relieve the pain.Groin pain was increasing when lifting, walking or standing for long periods.The patient also experienced fatigue, depression and anxiety.The patient stressed about decision making for mesh removal.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: 8212780
• MDR Text Key: 131933331
• Report Number: 2210968-2019-78140
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• 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: 12/20/2018
• 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