MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT; SKIN GRAFT PRODUCTS

Catalog Number 3539250

Device Problems Device Inoperable (1663); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported the dermatome device was not working as expected.At the beginning of the surgery the device began to have little power and was not working as it was expected.Suddenly, a strange noise was heard, which was shy it was automatically no longer used.It was reported the device was in contact with the patient; however, there was no patient injury.It was reported the procedure was delayed for two weeks.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4661853
• MDR Text Key: 5627320
• Report Number: 3004608878-2015-00109
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3539250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1