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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
Catalog Number PROMESHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Seroma (2069); Ambulation Difficulties (2544)
Event Date 04/07/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form.

 
Event Description

It was reported that the patient underwent an abdominal hernia repair procedure on unknown date and the mesh was implanted. The patient experienced complications include chronic abdominal, pubic and groin pain, pain in lower back, both hips and buttocks and leg pain associated with difficulty in walking, standing and sitting. The patient experienced sensation of incomplete bladder emptying and difficulty in passing urine. It was also reported that the patient experienced loss of appetite, weight loss and 5 stone. The patient is unable to move without tearing/burning sensation in abdomen and experiencing extreme sensitivity on skin area around wound site. Per patient, they experienced a pain in right arm and left leg. Seroma around wound site was aspirated once but returned. The patient is also unable to use the toilet without having to use movicol and experiencing irritable bowel. Additional information has been requested.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8326182
MDR Text Key135730156
Report Number2210968-2019-78809
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,OTHER
Reporter Occupation
Type of Report Initial
Report Date 01/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPROMESHUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/11/2019 Patient Sequence Number: 1
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