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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Seroma (2069); No Code Available (3191)

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.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.[(b)(4)].

Event Description

Title: evaluation of tapp efficacy and combined fixation of mesh implants for inguinal hernia repairs.The implementation of transabdominal preperitoneal approach (tapp) for inguinal hernia repairs has improved the treatment outcomes.It was reported that the usage of combined fixation of mesh in tapp repair will contribute to a reduction in the recurrence rate.The efficacy of tapp repair of inguinal hernias was evaluated in 128 patients aged 25-75.The patients were divided into two groups.In group i, (64 patients), a classical tapp was performed.In group ii (64 patients), an improved tapp was used: an ultrapro mesh implant (10 x 15 cm) which was fixed with protack hernia stapler at typical points.Sulfacrylate adhesive was used at the area of the iliopubic tract and iliac vessels.In group 2, reported complications included seroma (n-2; 3.12%) and hematoscheocele (n-3; 4.68%).It was concluded that tapp with combined fixation of mesh by use of protack hernia stapler at typical points and sulfacrylate adhesive at the area of the iliopubic tract and iliac vessels reduces the recurrence rate of inguinal hernias.It seems to be more effective in comparison with classical tapp.

• Brand Name: ULTRAPRO 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
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7499773
• MDR Text Key: 107772486
• Report Number: 2210968-2018-72682
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1