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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 Migration (4003)
Patient Problems Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120)
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. (b)(4) submitted for adverse event which occurred on (b)(6) 2019. (b)(4) submitted for adverse event which occurred on (b)(6) 2020.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and two (2) mesh products were implanted, due to pelvic organ prolapse and urinary incontinence. It was reported that the patient experienced recurrent urinary incontinence, vaginal bleeding, inflamed cervix, recurrent urinary tract infections, dyspareunia, chronic pain, foul smelling discharge, erosion of the mesh into her vaginal wall, and erosion of the other mesh into her cervix and adherence to her bowel. It was reported that the patient underwent surgical procedures on (b)(6) 2019 and (b)(6) 2020 to remove the products. 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
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 Key14199086
MDR Text Key293299414
Report Number2210968-2022-02952
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
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/25/2022 Patient Sequence Number: 1
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