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U.S. Department of Health and Human Services

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

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ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
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.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, 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 Key8212780
MDR Text Key131933331
Report Number2210968-2019-78140
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
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 Received01/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMESHUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/03/2019 Patient Sequence Number: 1
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