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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)
Event Date 08/25/2018
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: hernia (2018); 22:1045¿1050. Doi: https://doi. Org/10. 1007/s10029-018-1811-3. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that the ethicon product (prolene mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved?.

 
Event Description

It was reported in a journal article with title: use of polypropylene mesh in contaminated and dirty strangulated hernias: short-term results. The aim of this prospective observational cohort study is to evaluate the outcome of polypropylene mesh in the settings of bowel resection performed for strangulated hernias of the abdominal wall. Between 1st march 2015 and 31st august 2017, a total of 68 hernias required emergency surgery for incarceration; out of these 38 hernias could be reduced without resection of contents. The remaining 30 patients (22 male and 8 female; age range = 25 to 82 years; mean age = 49. 9 years) who required resection of gangrenous bowel and anastomosis constituted the study cohort. Surgery was performed using polypropylene mesh (prolene, ethicon). Reported complications included in the group where bowel resection and anastomosis was required were wound infection (n=8) which was managed conservatively with antibiotics and wound dressing by opening a few sutures, draining the collection, and irrigating with hydrogen peroxide and povidone iodine, and all of these wounds healed by secondary intention; seroma (n=10); recurrences (n=2) were observed and both patients had comorbid illness (diabetes and hypertension) and were elderly (> 60 years old). Both patients are on follow-up and have not yet opted for reoperation. In the group where hernias could be reduced, wound infection (n=2) was significantly less not requiring bowel resection; and seroma formation (n=11). In conclusion, the use of polypropylene mesh for contaminated and dirty strangulated hernias is effective and safe, with acceptable morbidity and good short-term results.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11738805
MDR Text Key263574740
Report Number2210968-2021-03922
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
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 03/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
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
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/28/2021 Patient Sequence Number: 1
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