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

Catalog Number PHSUNK

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

Patient Problems Abscess (1690); Hematoma (1884); Pain (1994); Hernia (2240); Discomfort (2330); 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: anz j.Surg.2004; 74: 343¿345.(b)(4).

Event Description

It was reported in a journal article title: single surgeon experience with bilayer polypropelene mesh repair of inguinal hernia open mesh repair of inguinal hernia has been shown to be an effective and safe method of hernia repair.In search of the ¿ideal¿ method of open mesh hernia repair, many different methods of mesh placement have been developed.The present study reports the singular experience of a general surgeon with this bilayer polypropylene mesh implant.This retrospective audit of the first 169 consecutive inguinal hernia repairs (age range: 21 to 99 years old; male to female ratio: 95:8) using the bilayer polypropylene hernia system (phs; ethicon) was conducted by mailed questionnaire and telephone interview.Reported complications included persistent discomfort/pain (21%), pain (n-2) which required medication, wound infection (n-5), which required oral antibiotics by the operating surgeon in 2 patients and the remaining 3 patients were treated by the general practitioner, wound abscess (n-1) which required wound exploration post-operatively in the operating theatre, wound hematoma (n-1) which required wound exploration post-operatively in the operating theatre, and recurrent hernia (n-1) which was repaired by another surgeon.The present review shows that the technique of bilayer mesh hernioplasty for primary or recurrent inguinal hernia is safe and is associated with low recurrence and complication rates.Brosis.

• Brand Name: PROLENE HERNIA SYSTEM 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: 8423415
• MDR Text Key: 138893423
• Report Number: 2210968-2019-79493
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHSUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2019
• 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