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

Catalog Number VYPROUNK

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

Patient Problems Hematoma (1884); Inflammation (1932); Seroma (2069); Urinary Retention (2119); Hypoesthesia (2352); 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: hernia (2004) 8: 127¿134 / doi 10.1007/s10029-003-0192-3.(b)(4).

Event Description

It was reported in a journal article with title: early results of a single-blinded, randomized, controlled, internet-based multicenter trial comparing prolene and vypro ii mesh in lichtenstein hernioplasty.The purpose of this single-blinded, randomized, controlled, internet-based multicenter trial was to compare a standard polypropylene mesh with the new polypropylene/polyglactin mesh in the lichtenstein operation.From dec 2000 to aug 2002, a total of 591 male patients, more than 25 years of age, with a unilateral primary inguinal hernia were eligible to participate in the study.The patients were randomized to lichtenstein¿s operation with either: prolene mesh group (n=295, mean age 54 years) or vypro ii mesh group (n=296, mean age 55 years).A piece of 7.5 x 15-cm prolene (ethicon) or vypro ii (ethicon) mesh was used according to the assigned group.Postoperative complications included prolonged postoperative pain or neuralgia (n=9, n=7 from prolene, n=2 from vypro ii); seroma (n=5, n=2 from prolene, n=3 from vypro ii); hematoma (n=25, n=11 from prolene, n=14 from vypro ii) which one patient needed reoperation with evacuation of the hematoma on the day of the operation under vypro ii group; urinary tract infection (n=1); testis atrofia (n=1); sensory loss (n=3, n=2 from prolene, n=1 from vypro ii); urinary retention (n=1); and ischemic orchitis (n=1).Lichtenstein¿s operation with either prolene or vypro ii is safe and well tolerated with an acceptable postoperative rehabilitation time and a high quality of life 2 months after surgery.

• Brand Name: VYPRO 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.-GMBH; robert-koch strasse 1; norderstedt 22851 ; GM 22851
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8915696
• MDR Text Key: 155049472
• Report Number: 2210968-2019-85928
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K002672
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VYPROUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• 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