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

Catalog Number ULTRAPROMUNK

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

Patient Problems Granuloma (1876); Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Foreign Body In Patient (2687)

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: 10 klinichna khirurhiia.2009; no.9.

Event Description

Title: rational management of patients after the operation for abdominal hernia using composite allotransplants the objectives of the study was to improve the early and long-term treatment outcome in patients with post-operative abdominal hernia.The results of treatment of 50 patients, to whom anterior abdominal alloplastic hernioplasty was done, using ultrapro light-weighted large-pore composite mesh (ethicon), were analyzed postoperatively pathogenetically substantiated prophylaxis of early and remote complications.The comparative group included 62 patients, to whom anterior abdominal wall alloplasty was performed, using prolene polypropylene mesh (ethicon).In the ultrapro composite mesh group, reported complications included seroma (n-8), infiltrates (n-5), hematoma (n-2), foreign body sensation (n-2), chronic pain in the implantation site (n-4), restriction of anterior abdominal wall mobility (n-3), granuloma of the anterior abdominal wall (n-1), and recurrence of hernia (n-1).In the prolene polypropylene mesh group, reported complications included seroma (n-17), infiltrates (n-7), hematoma (n-3), foreign body sensation (n-8), chronic pain in the implantation site (n-9), restriction of anterior abdominal wall mobility (n-8), skin-prosthetic fistula (n-2), granuloma of the anterior abdominal wall (n-5), and recurrence of hernia (n-3).Alloplasty of the anterior abdominal wall using composite allotransplants with large pores is an effective way of treating patients with postoperative abdominal hernias and improves the long-term results of surgical intervention without increasing the incidence of recurrences.The individualized administration of combined drug therapy, pathogenetically based approaches to post-operative management of patients, magnetic therapy, magnetic-laser effects or low-frequency electrotherapy helped to reduce the incidence of complications after alloplasty of the abdominal wall, and, if they were detected, it helped rapidly eliminate these complications, reduce the duration of rehabilitation period in the patients, improve their life quality.

Manufacturer Narrative

Article attached - (b)(4).

• 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
• MDR Report Key: 8961177
• MDR Text Key: 156773988
• Report Number: 2210968-2019-86546
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAPROMUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention