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

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (prolene hernia system) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved?" 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: hernia (2015) 19:77¿81; doi 10.1007/s10029-014-1295-8.[(b)(4)].

Event Description

It was reported in a journal article with title: long-term outcome after randomizing prolene hernia system, mesh plug repair and lichtenstein for inguinal hernia repair.This study aimed to assess long-term superiority in terms of chronic pain between prolene hernia system (phs), mesh plug repair (mpr) and lichtenstein (l) technique for inguinal hernia repair.Between apr2001 and mar2003, 270 patients had been blindly and randomly allocated to receive an open anterior inguinal hernia repair with phs (n=90; mean age sd of 55 [12] years; mean bmi of 24.4 [2.9] kg/m2), mpr (n=91; mean age sd of 54 [13] years; mean bmi 24.6 [2.7] kg/m2) or l technique (n=89; mean age of 54 [12] years; mean bmi 24.8 [2.7] kg/m2), and were included in the analysis.In the median leangth follow-up of 7.6 years, postoperative outcomes in phs group included mild pain (n=13), moderate pain (n=6), sometimes feeling the mesh (n=27), feeling the mesh a lot (n=4), numbness (n=11), and recurrence (n=3.3%).It can be concluded that long-term outcome after randomizing phs, mpr and l showed no clinically relevant differences.Although chronic pain was diminishing over time it remained a serious complication and had sometimes an onset long after the inguinal repair.

• 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: 8449010
• MDR Text Key: 139736349
• Report Number: 2210968-2019-79640
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• 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: 02/28/2019
• 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