MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA DERMATOME, UNKNOWN; SKIN GRAFT PRODUCTS

Catalog Number XXX-DERM

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A physician reported a dermatome (unknown id) "gouged patients" (blade shredded skin).The issue was located where blade and guard connect.The pin comes out and the blade seated improperly.The blade shredded skin and pin was too short.No additional information has been provided after several attempts.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h6, h10 the dermatome was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue 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.A corrective a preventative action has been reopened.No additional information is reportedly available for this complaint, however any further investigation will take place under the corrective action process.

• Brand Name: DERMATOME, UNKNOWN
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17383273
• MDR Text Key: 319621411
• Report Number: 3004608878-2023-00130
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DERM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• 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