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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Erythema (1840); 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. [(b)(4)].

 
Event Description

It was reported via journal article: "title: ambulatory inguinal hernia repair with prolene hernia system (phs)" authors: m. Farrakha, v. Shyam, g. A. Bebars, m. Yacoub, k. Bindu, s. Kolli citation: hernia. 2006; 10: 2¿6. Doi: 10. 1007/s10029-005-0007-9. The study was conducted to evaluate the feasibility and benefits of inguinal hernia repair with prolene hernia system (phs) mesh (ethicon) under local anesthesia as a day surgery procedure in a multinational society of united arab emirates. A total of 154 patients (age range: 18 to 74 years old) fitted the criteria and were included in the study. The hernia repair was performed by the placement of phs mesh. A preperitoneal space was then created behind the transversalis fascia for the placement of the deep layer of the phs mesh. The connecting cylinder of the phs mesh was fixed to the internal ring by one or two prolene sutures (ethicon), and the superficial layer of the phs mesh was spread onto the floor of the inguinal canal using few prolene 2-0 sutures (ethicon). Reported complications included scrotal edema (n-6), mild wound erythema (n-9), wound infection (n-1), and hernia recurrence (n-1) which was re-operated using the same technique. The present study has demonstrated that inguinal hernia repair with phs performed under local anesthesia, on a day-case basis, is safe and feasible procedure. It is associated with minimal postoperative morbidity, acceptable levels of postoperative pain, early mobilization, and reduced costs of hospitalization.

 
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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)
J-PAC
25 centre rd
somersworth NH 03878
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8445000
MDR Text Key139596762
Report Number2210968-2019-79614
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 02/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2019
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 Received02/26/2019
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: 03/22/2019 Patient Sequence Number: 1
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