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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-76743, subject of a litigation complaint summary exemption no. E2013037. 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).
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and mesh was implanted. It was reported that she experienced undisclosed injuries. It was reported that the patient underwent a revision surgery on (b)(6) 2016. No additional information was provided.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12696063
MDR Text Key281169381
Report Number2210968-2021-10310
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 09/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/26/2021 Patient Sequence Number: 1
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