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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Blood Loss (2597)
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 hernia repair surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient experienced chronic pain, infection, bleeding, internal organ injury and adhesions.Other procedure is captured under separate file.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 6/16/2020.Additional information: it was reported that following the procedure patient suffered disability, incontinence, and the loss of the enjoyment of life.
 
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Brand Name
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9699465
MDR Text Key185932804
Report Number2210968-2020-01097
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 foreign,other
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/07/2020
Initial Date FDA Received02/12/2020
Supplement Dates Manufacturer Received06/12/2020
Supplement Dates FDA Received06/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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