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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE SOFT MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number SPMLI34
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Micturition Urgency (1871); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This emdr represents supplemental report #2210968-2017-30584 for previously submitted mdr number 2210968-2017-30283. Subject of a litigation complaint summary exemption no.  e2013037.  the referenced exemption was revoked effective may 15, 2019.  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). (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. A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted. It was reported that the patient experienced urinary frequency, urgency, dysuria, urinary tract infections, vaginal discharge, apex of vagina, granulation tissue, yellow, white purulent material and green vaginal discharge. It was reported that the patient underwent removal surgery of vaginal cuff, granulation tissue on (b)(6) 2016. It was reported that the patient experienced vaginal discharge, pelvic abscess and infection on (b)(6) 2016. It was reported that the patient died on (b)(6) 2016. No additional information was provided.
 
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Brand NamePROLENE SOFT MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12678023
MDR Text Key281223114
Report Number2210968-2021-10140
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K133356
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2016
Device Catalogue NumberSPMLI34
Device Lot NumberDGH013
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/21/2021 Patient Sequence Number: 1
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