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

Catalog Number PROMESHUNK

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

Patient Problems Pain (1994); Hernia (2240); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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: surg endosc (2008); 22: 129¿133.Doi: 10.1007/s00464-007-9388-4.(b)(4).

Event Description

It was reported in a journal article with title: postoperative hypoesthesia and pain: qualitative assessment after open and laparoscopic inguinal hernia repair.The aim of this study was to objectively assess chronic hypoesthesia and pain after inguinal hernia repair using von frey monofilaments and to compare open suture, open mesh, and laparoscopic techniques.Between january 1995 and november 2003, a total of 96 patients who underwent clinical examination and completed questionnaires were included in the study.Patients were grouped according to the type of hernia repair: in group a, 40 patients (38 male and 2 female; median age: 61; age range: 28-77) underwent open suture repair using a modified two-layer shouldice repair 2-0 using a polypropylene suture; in group b, 20 patients (20 male; median age: 62; age range: 45-83) underwent open mesh repair using a standard lichtenstein procedure with prolene polypropylene mesh (ethicon); and in group c, 36 patients (31 male and 5 female; median age: 57; age range: 28-70) underwent laparoscopic hernia repair using a transperitoneal or preperitoneal approach.Reported complications in group b included recurrent hernia (n-1), overall postoperative pain (n-6), pain occurring at least once a week (n-5), hypoesthesia (n-65%), hypoesthesia in the sensory region of the ilioinguinal and genitofemoral nerves (n-45%), chronic pain (n-?) and allodynia (n-1).In conclusion, the incidence of hypoesthesia in patients who had laparoscopic hernia repair is significantly lower than in those who had open hernia repair.Hypoesthesia after laparoscopic but not after open repair is significantly associated with postoperative pain.

• Brand Name: PROLENE POLYPROPYLENE 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): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8895779
• MDR Text Key: 154415992
• Report Number: 2210968-2019-85587
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K962530
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• 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