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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
This emdr represents supplemental report #2210968-2017-30539 for previously submitted mdr number 2210968-2017-30283. Subject of a litigation complaint summary exemption no.  e2013037.  the referenced exemption was revoked effective may 15, 2019.  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). (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) 2000 and mesh was implanted. It was reported that she experienced undisclosed injuries. 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 Key12725546
MDR Text Key284873926
Report Number2210968-2021-10627
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 10/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2021
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 Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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