MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP. BILAYER

Lot Number 105A00165834

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Ulcer (2274); Pressure Sores (2326)

Event Date 04/27/2010

Event Type  Injury  

Event Description

It was reported as part of a study conducted titled: "a retrospective, multi-center study evaluating the outcomes for integra skin sheet bilayer or single layer products used in complex lower extremity soft tissue reconstruction." this is the second report of two reports concerning the same pt.See mfg report no: 1121308-2014-00017.The pt received integra bilayer implanted on (b)(6) 2010 to a wound, which was on the right plantar foot, had an etiology listed as ischemic diabetic neuropathic-ulcer, pressure ulcer.The wound's approximate measurement was 4cm length x 5cm width.After the initial index surgery with integra bilayer, the pt was readmitted on (b)(6), 2010 for negative pressure wound therapy (npwt) and a split thickness skin graft (stsg).On (b)(6)2010, the pt experienced a serious adverse event of "dehiscence." this event was documented as severe, possibly related to the initial index treatment with integra, and deemed ongoing at the time of 1 year f/u.The action taken was receipt of concomitant medications/therapy (not specified) and readmission and reoperation.The pt was readmitted (b)(6), 2010 for npwt and a stsg and then again on (b)(6), 2011 for a local flap.This pt experienced a second adverse event on (b)(6) 2010 of "infection." this event was documented as moderate in severity, possibly related to the initial index treatment with integra, and considered not a serious event.The action taken was receipt of concomitant medications/therapy (oral antibiotics not specified).The event was deemed resolved (b)(6) 2010.

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based upon the reported info.

• Brand Name: BILAYER
• Type of Device: BILAYER
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP.; plainsboro NJ 08536
• Manufacturer Contact: caren finfelstein ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3879367
• MDR Text Key: 4568405
• Report Number: 1121308-2014-00018
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Lot Number: 105A00165834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention