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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 Unspecified Infection (1930); Hernia (2240); Post Operative Wound Infection (2446); Not Applicable (3189)
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: asian journal of surgery (2012) 35, 149e153 / http://dx. Doi. Org/10. 1016/j. Asjsur. 2012. 06. 003. (b)(4).

 
Event Description

It was reported in a journal article title: the use of synthetic mesh in patients undergoing ventral hernia repair during colorectal resection: risk of infection and recurrence. The purpose if this retrospective study was to evaluate the risk of infection and hernia recurrence for patients undergoing repair of ventral hernia (vh) with prosthetic mesh during colorectal resection. Between dec 2000 and aug 2007, a total of 40 patients [n=24 male, n=16 female, mean age 61 years (sd 12. 5 years), median body mass index (bmi) was 29 kg/m2] with colorectal cancer, diverticulitis and inflammatory bowel disease underwent repair with non-absorbable mesh. Prolene mesh was used in all patients. Postoperative complications included wound infection (n=?); hernia recurrence after elective surgery (n=11); hernia recurrence after emergency surgery (n=5); mesh infection (n=9) wherein five of these patients required readmission for excision of the mesh; and delayed mesh infection (n=3) wherein one was treated by mesh excision whereas the other two were treated conservatively. Use of non-absorbable mesh during colorectal resection should be very selective. Comorbidity, duration of follow-up, emergency operations, size of area covered and infection are independent factors associated with recurrence.

 
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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 Key8894179
MDR Text Key154317785
Report Number2210968-2019-85552
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeEG
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 07/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2019
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 Received07/18/2019
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: 08/14/2019 Patient Sequence Number: 1
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