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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MERS MESH MESH, SURGICAL

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ETHICON INC. MERS MESH MESH, SURGICAL Back to Search Results
Catalog Number RML
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Erosion (1750); Incontinence (1928); Abnormal Vaginal Discharge (2123); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

 
Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2001 and mesh was implanted. It was reported that she experienced undisclosed injuries. It was reported that the patient underwent a revision surgeries on an unknown date. No additional information was provided.

 
Manufacturer Narrative

Date sent to fda: (b)(4) 2018. It was reported that the patient experienced exposed mesh, vaginal discharge, and incontinence. It was reported that the patient underwent mesh removal surgery on (b)(4) 2014. No additional information was provided.

 
Manufacturer Narrative

Date sent to fda: (b)(4) 2018.

 
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Brand NameMERS MESH
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.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7753658
MDR Text Key116145917
Report Number2210968-2018-74868
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2005
Device Catalogue NumberRML
Device LOT NumberPKE236
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/08/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/06/2018 Patient Sequence Number: 1
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