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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 10INX10IN MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE SOFT MESH 10INX10IN MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number SPMLI
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Prolapse (2475); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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) 2007 and mesh was implanted. It was reported that the patient underwent revision surgery on (b)(6) 2019. It was reported that the patient experienced undisclosed adverse event. No additional information was provided.
 
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Brand NamePROLENE SOFT MESH 10INX10IN
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 Key11625448
MDR Text Key253512987
Report Number2210968-2021-03087
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2012
Device Catalogue NumberSPMLI
Device Lot NumberZDR042
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 Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/06/2021 Patient Sequence Number: 1
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