MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP. PADGETT; DERMATOME

Device Problems Power Conditioning Problem (1474); Device Stops Intermittently (1599)

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Date 12/11/2016

Event Type  malfunction  

Manufacturer Narrative

The following elements have blank data.

Event Description

Dr.Was performing stsg with integra dermatome.It made a shorting out noise, stopped, and then worked.They were able to complete the stsg.The dermatome was not tagged and was reprocessed.Later that same week, the same physician was doing another stsg and it made a noise, only this time it stopped completely.The skin was unable to be saved, so a new graft site was prepped and obtained.The dermatome was tagged and sent out for repair.

• Brand Name: PADGETT
• Type of Device: DERMATOME
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP.; 4900 charlemar dr.; building a; cincinnati OH 45227
• MDR Report Key: 6215437
• MDR Text Key: 63637279
• Report Number: 6215437
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other