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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 3INX6IN MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE MESH 3INX6IN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PMII
Device Problem Migration (4003)
Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275)
Event Type  Injury  
Manufacturer Narrative
This emdr represents supplemental report # 2210968-2017-32614 for previously submitted mdr number 2210968-2017-32099, subject of a litigation complaint summary exemption no. E2013037. The referenced exemption was revoked effective may 15, 2019. The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www. Fda. Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr. Therefore, this report does not represent a new reportable event. The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under (b)(4) (ethicon¿s internal reference number). 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. In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted. It was reported that following insertion the patient experienced chronic pelvic pain, stress urinary incontinence, nocturia, urinary frequency, urinary urgency, erosion of her internal bodily tissue following the procedure, and incomplete bladder emptying. It was reported that the patient underwent revision surgeries on unknown dates. No additional information was provided.
 
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Brand NamePROLENE MESH 3INX6IN
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12733720
MDR Text Key284971641
Report Number2210968-2021-10676
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031049024
UDI-Public10705031049024
Combination Product (y/n)N
PMA/PMN Number
K180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2015
Device Model NumberPMII
Device Catalogue NumberPMII
Device Lot NumberCLR510
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/01/2021 Patient Sequence Number: 1
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