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 Hematoma (1884); Unspecified Infection (1930); Swelling (2091); Burning Sensation (2146); Hernia (2240); Urinary Frequency (2275); 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: world j surg (2007) 31:1751¿1757; doi 10.1007/s00268-007-9090-7.(b)(4).

Event Description

It was reported in a journal article with title: pain after open preperitoneal repair versus lichtenstein repair: a randomized trial.The purpose of this trial was to compare an open preperitoneal to an open anterior approach in terms of chronic pain, as such a study has not been reported before.Between dec2004 and sep2005, 172 patients with primary unilateral inguinal hernia were randomly underwent either open preperitoneal kugel (n=86; n=85 male and n=1 female; mean age of 55.6 years [sd15.8]; mean bmi of 25.1 kg/m2 [sd2.9])or the standard open anterior lichtenstein procedure (n=86; n=85 male and n=1 female; mean age of 54.4 years [sd13.6]; mean bmi of 25.4 kg/m2 [sd2.7]).In lichtenstein procedure, a 6x11 cm prolene mesh was trimmed to fit the inguinal floor, as necessary.The mesh was sutured to the ligament of poupart with a non-absorbable suture and secured cranially using an absorbable suture.In lichtenstein procedure, complications included hematoma (n=14), infection (n=5), dysejaculation (n=1), swelling/bulging (n=12) and urinary frequency (n=1) which ct scan showed mesh on the bladder, treated with removal of the preperitoneal mesh resolved the problem and definitive hernia repair was planned.Two recurrences were recorded treated with reoperation (n=? unspecified per group).This recurrences were regarded as technical failure.The level of experience of the supervising surgeon was not specified, and it is therefore possible that a procedure carried out under less experienced supervision might have failed, thereby contributing to the recurrence rate.The kugel procedure is a feasible alternative for the standard lichtenstein procedure and is associated with less chronic pain at three months.Most likely the neuropathic pain and numbness with the lichtenstein technique are results of more nerves at risk with the anterior approach.

• 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: 8931904
• MDR Text Key: 156433361
• Report Number: 2210968-2019-86171
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• 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: 07/31/2019
• 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