MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA 13-FOOT CABLE FOR MODEL S ELECTRIC DERMATOME; SKIN GRAFT PRODUCTS

Catalog Number 353971513

Device Problem Insufficient Information (3190)

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

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint sample 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.

Event Description

Medwatch repot number: fda (b)(4).It was reported the dermatome malfunctioned during a procedure resulting in a sub-optimal skin graft.Surgeon had to use scissors to complete the proper cut.No patient injury.

• Brand Name: 13-FOOT CABLE FOR MODEL S ELECTRIC DERMATOME
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10731579
• MDR Text Key: 213042125
• Report Number: 3004608878-2020-00636
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 353971513
• Date Manufacturer Received: 09/28/2020
• 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
• Patient Age: 24 YR