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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); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Hematuria (2558); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This emdr represents supplemental report #2210968-2014-16518 for previously submitted mdr number 2210968-2014-15562 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 The referenced exemption was revoked effective may 15, 2019.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. (b)(4). A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2005 and mesh was implanted. It was also reported that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted. It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that the patient has undergone multiple surgeries and revisionary procedures. It was reported that following insertion the patient experienced infection, urinary/bowel problems, recurrence, bleeding, and neuromuscular problems. It was reported that the patient underwent removal surgery on (b)(6) 2017. It was reported that the patient experienced blood in her urine. 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
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12817908
MDR Text Key285338503
Report Number2210968-2021-11493
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2016
Device Model NumberPMII
Device Catalogue NumberPMII
Device Lot NumberDBP120
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2011
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: 11/15/2021 Patient Sequence Number: 1
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