MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION BILAYER MATRIX WOUND DRESSING; BMWD

Catalog Number XXX-BWM

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Hand journal (2018) published: "use of integra in the management of complex hand wounds from cancer resection and nonburn trauma." purpose: this study aimed to review outcomes following integra use for hand reconstruction following cancer resection or nonburn trauma with exposed bone, joints, and/or tendons.Methods: retrospective review was performed of patients undergoing hand reconstruction with integra for exposed bones, joints, or tendons over a 6-year period at a single institution.Results: fourteen patients underwent hand reconstruction using integra, 8 following cancer resection and 6 following acute nonburn trauma.The mean defect size was 19 cm2 , 79% had exposed tendon without peritenon, 43% had exposed bone without periosteum, and 28% had exposed joint capsule.Mean time from integra to skin graft was 11.3 days, and negative-pressure wound therapy did not significantly decrease the mean time from integra to skin graft placement (p =.76).Overall, 13 patients achieved successful reconstruction with mean skin graft take of 97%, and 1 required revision amputation at the proximal interphalangeal (pip) joint.Six months postoperative, 92% patients had return of preoperative hand function.Without any surgical revision, 85% of patients were extremely satisfied with the aesthetic result and 15% were fairly satisfied.Adverse event complaint ¿ ¿revision amputation at the proximal interphalangeal joint after failure of integra.¿ conclusion: integra is an effective method to treat complex hand wounds with exposed bone, joints, and/or tendons.This technique can be used in the office, lessens the need for local or free flap coverage, and provides an excellent aesthetic outcome.Integra should be considered a viable option in hand reconstruction algorithm.Doi:i0.1177/i5589447i7692090.

Event Description

N/a.

Manufacturer Narrative

The bilayer dermal regeneration template was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: BILAYER MATRIX WOUND DRESSING
• Type of Device: BMWD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• MDR Report Key: 10400662
• MDR Text Key: 202737985
• Report Number: 1121308-2020-00042
• Device Sequence Number: 1
• Product Code: KGN
• Combination Product (y/n): N
• PMA/PMN Number: K021792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-BWM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1