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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 Skin Discoloration (2074); Hernia (2240); Post Operative Wound Infection (2446)
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: langenbecks arch surg (2010); 395:575¿579. Doi: 10. 1007/s00423-008-0326-2. (b)(4).

 
Event Description

It was reported in a journal article title: prosthetic repair of incarcerated inguinal hernias: is it a reliable method? the objective of this retrospective study is to compare the outcomes of incarcerated inguinal hernia repair with or without graft in terms of postoperative morbidity, mortality, and recurrence after long-term follow-up. This retrospective, nonrandomized study involves 131 patients (108 male and 23 female; mean age: 58. 4±18. 7; age range: 15-92 years) with incarcerated inguinal hernia who underwent surgery between january 1998 and february 2007. Patients were divided into two groups; in group 1, 29 patients (22 male and 7 female; mean age: 69. 4±14. 1) underwent lichtenstein (tension free) repair in which the tension-free hernioplasty was performed using prolene polypropylene mesh (ethicon) and a 2/0 prolene suture (ethicon) to fix mesh in the desired position, and in group 2, 102 patients (86 male and 16 female; mean age: 52. 1±22. 7) underwent primary hernia repair (bassini or andrews technique). Reported complications in group 1 included recurrence (n-1), wound infection (n-3) which were successfully managed with drainage and local wound care, and scrotal ecchymosis (n-1). In conclusion, mesh repair can be preferred in incarcerated inguinal hernia patients because recurrence rate was significantly lower in patients who underwent lichtenstein repair in this study.

 
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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 Key8891187
MDR Text Key154407041
Report Number2210968-2019-85514
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 07/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2019
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 Received07/17/2019
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: 08/13/2019 Patient Sequence Number: 1
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