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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 Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Scar Tissue (2060); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and prolene soft mesh was implanted.It was reported that patient experienced pain in her lower abdomen, increasing dyspareunia with bleeding, prolapse, discomfort, erosion, scarring and incontinence.No additional information was provided.
 
Manufacturer Narrative
(b)(4).This emdr represents supplemental report # (b)(4)for previously submitted mdr number 2210968-2018-76743, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective (b)(6) 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.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) (ethicon¿s internal reference number).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.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
 
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Brand Name
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12686056
MDR Text Key284516669
Report Number2210968-2021-10211
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
Report Date 10/22/2021
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 04/18/2019
Initial Date FDA Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age42 YR
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