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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
Event Type  Injury  
Manufacturer Narrative

(b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: arch surg/vol 144 (no. 11), nov 2009. Please see article attached. (b)(4).

 
Event Description

It was reported in a journal article title: abdominal wall reconstruction this comprehensive retrospective medical record review aimed to determine the efficacy and describe the evolution of the ¿components separation¿ technique for abdominal wall repair in 200 consecutive patients. Between 02aug1996 and 02jul2007, 200 patients (n=115 male and n=85 female; mean age of 54. 2 years) underwent ventral hernia repair using components separation technique for midline abdominal wall defects. These patient were divided based on the technique: no mesh (n=158); and primary underlay mesh repair (n=42) using prolene mesh (n=6; n=4 male and n=2 female; mean age of 48. 5 [10. 4] years [ranged 31-59 years]), human acellular cadaveric dermis (n=18) and soft polypropylene mesh (n=18; n=9 male and n=9 female; mean age of 53. 8 [sd13] years [ranged 27-73 years]). In patients who utilized soft polypropylene mesh, prolene soft mesh and proceed surgical mesh; ethicon inc, (b)(6)) was used as an intra-abdominal reinforcement of the midline closure in clean cases without bowel injury and when the omentum could be situated under much of the mesh. Postoperatively, in patients who utilized prolene mesh, complications included hernia recurrence (n=1), major complications (n=1) and minor complications (n=2). While in patients who utilized either prolene soft mesh or proceed surgical mesh, complications included major complications (n=3) and minor complications (n=3). Most of the aforementioned hernia recurrences were successfully treated by direct reapproximation of the rectus abdominis muscles in the midline, reinforced by a non bridging intra-abdominal soft polypropylene mesh. Large complex hernias can be reliably repaired using the components separation technique despite the presence of open wounds, the need for bowel surgery, and numerous comorbidities.

 
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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 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville , NJ 08876-0151
9082182792
MDR Report Key8849215
Report Number2210968-2019-84974
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 07/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2019
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 Received07/05/2019
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: 07/31/2019 Patient Sequence Number: 1
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