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

Catalog Number PHSMUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Fever (1858); Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240)

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: rozhl chir.2002 nov; 81, suppl 1: s27-30.(b)(4).

Event Description

It was reported in a journal article with title: "phs mesh ¿ initial experience." this study aimed to present a new method for tension free inguinal hernioplasty with the use of phs ¿ prolene hernia system ¿ mesh.Between oct 1999 and feb 2002, 88 male patients with median age of 55.3 years (20 - 90) with 97 primary or recurring inguinal hernias were operated with tension free inguinal plastic operation using prolene hernia system mesh.Folded phs mesh is inserted into the space prepared.The inner round part (underlay patch) is carefully unfolded in the preperitoneal area with a finger so that the defect in the abdominal wall is completely covered.The central portion is positioned in the place of defective internal inguinal anulus and oval upper layer (onlay patch) is positioned longitudinally from within to the base of the inguinal canal.Complications included hematoma in the subcutaneous tissue in the area of the wound and on the scrotum (n=12), seroma in the wound (n=4), subfebrile fever of 38°c (n=9), pain and edema of the testicle (n=4) which subsided quickly; and a relapse (n=1).In conclusion, phs mesh hernioplasty have very good results in terms of length of morbidity, return to normal physical activity and in terms of recurrence.

• Brand Name: PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT
• Type of Device: MESH, 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 Key: 8478705
• MDR Text Key: 140812167
• Report Number: 2210968-2019-79961
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHSMUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention