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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

(b)(4). The single complaint was reported with multiple events through a journal article. No specific patient information regarding events has been provided and it is unknown if the events have been previously reported. The manufacturing record evaluation cannot be reviewed as the lot number has not been provided. Reference journal article. [(b)(4)].

 
Event Description

It was reported in a journal article entitled: comparison of tension-free hernia repair under local anesthesia in adults: comparison of phs and perfix. Author: jee-man you, kwang-man lee and un-jong choi. Citation: journal of the korean surgical society: vol. 72, no. 1, january 2007. The purpose of this comparative study was to compare the feasibility of phs® and perfix® procedures under local anesthesia, which are commonly used as tension-free herniorrhaphy in adults, and the difference between the two methods. Between march 2003 to february 2006, 107 patients with mean age of 63. 8 years (range 24-91 years) who underwent tension-free herniorrhaphy under local anesthesia were included in the study. The meshes were randomly used. The phs group consisted of 63 patients (male n=56 and female n=7) with mean age of 66. 1 years and the perfix group have 44 patients (male n=43 and female n=1) with mean age of 60. 5 years. The underlay patch of the phs® mesh was inserted into bogros' space and retzius' space and the onlay patch was fixed with 3-0 prolene® to the cervical ligament, internal transverse muscle and transverse abdominal muscle. In the case of the perfix® mesh, the plug was inserted into the internal inguinal ring and fixed with 3-0 prolene®, and the onlay patch was fixed in the same manner as phs®. Complications in the phs group included wound infection (n=1) and chronic pain (n=1). Complication in the perfix group included wound infection (n=1). In conclusion, with tension-free herniorrhaphy using the phs or perfix mesh, local anesthesia was acceptable and securable, regardless of the mesh type used. Among the patients, those at an older age and with a lower bmi were more tolerant to local anesthesia.

 
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Brand NamePROLENE HERNIA SYSTEM 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 Key8502299
MDR Text Key141566602
Report Number2210968-2019-80242
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCH
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 03/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2019
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: 04/10/2019 Patient Sequence Number: 1
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