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); Fever (1858); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Paralysis (1997); Swelling (2091); Hernia (2240); Urticaria (2278); Discomfort (2330); Hematuria (2558); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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: surg today.2014; 44: 2255¿2262.Doi: 10.1007/s00595-014-0867-7.(b)(4).

Event Description

It was reported in a journal article with title: "short- and long-term outcomes of open inguinal hernia repair: comparison of the prolene hernia system and the mesh plug method." tension-free mesh repair of adult inguinal hernias has become a standard procedure, but there have been few comparisons of the postoperative outcome after hernia repair using the prolene hernia system (phs; ethicon) versus the mesh plug (mp) method.The authors reviewed the medical records of patients to investigate the short and long term outcomes of the different types of hernia repair.A total of 1141 repairs (age range: 16 to 95 years old; 1020 male and 121 female patients) were performed (957 cases in phs and 184 repairs in mp).The mp was used as a standard device for tension-free hernia repair, while the phs was introduced in february 2000.The phs is a bilayer polypropylene mesh device, in which the deep layer supports the inguinal canal floor and covers the entire myopectineal orifice, while the superficial layer protects the groin anterior.In the phs group, reported short-term outcomes included fever (n-37), wound pain requiring bed rest (n-15), subcutaneous hematoma (n-12), scrotal swelling (n-3), miscellaneous (n-5), urticaria (n-1), hematuria (n-1), and subcutaneous emphysema (n-1).Reported long-term outcomes in the phs group included recurrence (n-14), wound infection (n-3) which required incisional drainage of an abscess in 1 patient and the phs was removed in the other 2 patients, mild pain (n-128), moderate pain (n-3), discomfort (n-8), bulge (n-7), prickling sensation (n-6), dysuria (n-4), and sensory paralysis (n-2).In conclusion, this retrospective analysis of a large cohort of patients treated at a single center showed that there were no significant differences in the overall early postoperative complications, long-term wound pain, recurrence and wound infection between patients undergoing phs or mp repair.The method used for repair should be selected according to the patient characteristics (with or without anticoagulant therapy) and the hernial anatomy (small or large orifice).

• 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: 8427804
• MDR Text Key: 139043035
• Report Number: 2210968-2019-79530
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/18/2019
• 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