MAUDE Adverse Event Report: INTEGRA: 311 ENTERPRISE DR. DERMATOME; PADGETT DERMATOME INSTRUMENT

Model Number MODEL B

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 06/01/2014

Event Type  Injury  

Event Description

Received notification on (b)(6) 2014 from operating room that the surgeon was performing a split thickness skin graft.While harvesting the skin, it was reported that the unit cut out while in use.This is reported that it caused a skipped effect on the patient's thigh rendering the harvest of tissue not useable.Harvest site cleaned.Procedure not completed.Patient is being sent to a specialist for the skin graft.Possibly problems for patient is leaving a permanent scar.Patient is a slow healer, so patient has the possibility of infection and harvest site not healing or slow to heal.Patient discharged home with (b)(6) on (b)(6) 2014.Have talked with (b)(4) at integra and offered for them to come on site to inspect the device.

• Brand Name: DERMATOME
• Type of Device: PADGETT DERMATOME INSTRUMENT
• Manufacturer (Section D): INTEGRA: 311 ENTERPRISE DR.; plainsboro NJ 08536
• MDR Report Key: 3891242
• MDR Text Key: 4426913
• Report Number: 3891242
• Device Sequence Number: 1
• Product Code: GFD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2014
• Distributor Facility Aware Date: 06/01/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 37 YR