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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
Catalog Number PHSUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Seroma (2069); 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: egyptian journal of surgery vol. (21), no. (4), oct. , 2002. (b)(4).

 
Event Description

Title: prolene hernia system repair of inguinal hernias. This study aimed to present the prolene hernia system (phs) repair in treating inguinal hernias. A total of 55 male patients with 60 inguinal hernias underwent herniotomy and mesh hernioplasty using phs. In the procedure, the phs was inserted directing the tips of the forceps toward the umbilicus. No sutures were used in the underlay part of the mesh. Once the mesh was in place, one finds it secure and immobile. Closure of the inguinal canal by suturing the external oblique will further fix the mesh in place. However, it could be secured by 3/0 vicryl stitches to the pubic tubercle, inguinal ligament and arching fibers of the internal oblique. Postoperative complications included mild subcutaneous wound infection (n=2) which resolved after administration of co-amoxyclav po without the need to open the wound or remove the mesh; seromas (n=3) that resolved after aspiration; and mild postoperative pain (n=?). The phs is a good method of repair of inguinal hernias, it provides some advantages like, technical ease, minimal suturing, less postoperative pain, and triple mesh support.

 
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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 Key8454246
MDR Text Key139967016
Report Number2210968-2019-79694
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeEG
PMA/PMN NumberK984220
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 02/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPHSUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
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: 03/26/2019 Patient Sequence Number: 1
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