INFORCE REINFORCEMENT MESH (FORTAFLEX MESH)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-15 for INFORCE REINFORCEMENT MESH (FORTAFLEX MESH) manufactured by Organogenesis, Inc..

Event Text Entries

[6011125] On (b)(6) 2015, the complaints manager from integra life sciences, notified organogenesis that info had been received from a sales rep from mountain medical indicating that following a tendon repair surgery in the foot where inforce was used, the "wound started to dehisce a month after it had healed". This info was initially received as part of a medical inquiry from the sales rep to integra product manager and no add'l details regarding the event were provided. On (b)(6) 2015, add'l info was provided from the sales rep in response to f/u inquiries that indicated the graft had been removed, however, no add'l detail was provided at that time. On (b)(6) 2015, oi was provided with info obtained from the treating clinician that verified that a revision surgery had been performed and the tendon had been debrided and the product had been removed. Add'l details regarding the event were also provided by the treating clinician at that time. The treating clinician reported. "pt was taken to surgery on (b)(6) 2015 scheduled for a primary repair of a achilles tendon tear. A v to y gastroc recession was also provided. The intergra inforce graft was used. The first graft opened was deemed to be too small for the watershed correction. The smaller graft was placed to reinforce the gastroc recession and a larger graft was place about the watershed repair. The pt was placed in a posterior splint. Sutures were removed on (b)(6) 2015 and the surgical site was deemed to be well healed. The pt was placed in a short leg fiberglass cast, non-weight bearing. On (b)(6) 2015, the pt was seen with a complaint of sanguineous drainage. Cast was removed and a dehiscence was documented at the watershed. The wound was cultured and the pt was then placed in a posterior splint. Would care efforts continued with compression dressings. A cluster of smaller wounds later developed about the proximal incision over the gastroc recession where second graft was placed. The pt was eventually referred to plastics and the tendon was later debrided and all graft product was removed surgically with the debridement of the tendon. The wound and incision promptly healed thereafter".
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1221816-2015-00004
• MDR Report Key: 4920918
• Report Source: 05
• Date Received: 2015-07-15
• Date of Report: 2015-07-15
• Date of Event: 2015-01-26
• Date Mfgr Received: 2015-04-20
• Device Manufacturer Date: 2012-12-28
• Date Added to Maude: 2015-07-20
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: PATRICK BILBO, SVP, REGULATORY AN
• Manufacturer Street: 150 DAN RD.
• Manufacturer City: CANTON MA 02021
• Manufacturer Country: US
• Manufacturer Postal: 02021
• Manufacturer Phone: 7814011155
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INFORCE REINFORCEMENT MESH (FORTAFLEX MESH)
• Generic Name: SURGICAL MESH
• Product Code: MGR
• Date Received: 2015-07-15
• Lot Number: IF121126GA
• Device Expiration Date: 2015-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORGANOGENESIS, INC.
• Manufacturer Address: CANTON MA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-07-15