MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION PADGETT; DERMATOME

Model Number 1594

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

Event Type  Injury  

Event Description

Dermatome was used to take a skin graft was leaking black fluid.Due to malfunction of the dermatome, more skin was required to be removed than usual.Manufacturer response for dermatome, dermatome (per site reporter).Returned for pin adjustment (under warranty).

• Brand Name: PADGETT
• Type of Device: DERMATOME
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterpriose drive; plainsboro NJ 08536
• MDR Report Key: 8980751
• MDR Text Key: 157101685
• Report Number: 8980751
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/02/2019,07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2019
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 3650 DA