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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSMUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Inflammation (1932); Pain (1994); Seroma (2069); Urinary Retention (2119); Urinary Tract Infection (2120); 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: the american journal of surgery 193 (2007) 697¿701; doi:10. 1016/j. Amjsurg. 2006. 08. 087. (b)(4).

 
Event Description

It was reported in a journal article with title: improved outcomes with the prolene hernia system mesh compared with the time-honored lichtenstein onlay mesh repair for inguinal hernia repair. The objective of this retrospective study was to compare the outcomes of the lichtenstein method of hernia repair with that of the prolene hernia system (phs) mesh, and hypothesized that the recurrence rates with the phs mesh repair would be lower than the lichtenstein onlay mesh repair (lmr) with similar complication rates and total operative times. From jan2003 to jul2005, 321 patients (age pf 58. 5 years) underwent phs mesh repair for inguinal hernia. In the procedure, the underlay of the phs mesh was then deployed into this space through the floor. The overlay was then sutured to the pubic tubercle, conjoint tendon, and the shelving edge of the inguinal ligament as described above. The extended portion of the overlay was placed under external oblique laterally. Immediate postoperative complications included urinary retention (n=2. 2%), urinary tract infection (n=0. 3%), hematoma or seroma (n=6. 9%), orchitis (n=1. 2%), wound infection (n=2. 8%), and neuralgia or other pain (n=2. 2%). Long-term complications included hematoma or seroma (n=0. 9%), neuralgia or other pain (n=1. 6%) and recurrence (n=0. 6%). The phs mesh provides complete coverage of the entire myopectineal orifice through the underlay placed in the preperitoneal space, which protects the medial and femoral triangles, and the overlay, which protects the lateral triangle of the myopectineal orifice. The phs mesh method for inguinal hernia repair was associated with a lower recurrence rate as well as fewer complications when compared with the lichtenstein onlay mesh repair technique.

 
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Brand NamePROLENE HERNIA SYSTEM 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 Key8439056
MDR Text Key139421450
Report Number2210968-2019-79591
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 02/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPHSMUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
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: 03/20/2019 Patient Sequence Number: 1
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