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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Erosion (1750); Unspecified Infection (1930); Injury (2348); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
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) 2005 and mesh was implanted.It was reported that she experienced undisclosed injuries.No additional information was provided.
 
Manufacturer Narrative
Patient code: 3189 - surgical intervention.It was reported that patient underwent excision of mesh on (b)(6) 2011 and (b)(6) 2015 due to infection and erosion.(b)(4) submitted for adverse event which occurred on (b)(6) 2011.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.
 
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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 0151
MDR Report Key8846612
MDR Text Key152806283
Report Number2210968-2019-84859
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,Followup
Report Date 10/14/2019
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 07/24/2019
Initial Date FDA Received07/31/2019
Supplement Dates Manufacturer Received08/29/2019
10/14/2019
Supplement Dates FDA Received08/30/2019
10/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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