MAUDE Adverse Event Report: INTEGRA LIFESCIENES CORP. /INTEGRA PAIN MANAGEMENT CRANIAL ACCESS KITS 3M HEALTHCARE; DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)

Catalog Number	INSHITH
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Product recall for hca houston healthcare cranial access kits containing steri-drape surgical drapes- an investigation identified that the liner on the adhesive component of the drapes is difficult to remove without damaging the product and rendering the product unusable.There was an observed increase in reported adhesive-related skin injuries for these affected lots.

• Brand Name: CRANIAL ACCESS KITS 3M HEALTHCARE
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)
• Manufacturer (Section D): INTEGRA LIFESCIENES CORP. /INTEGRA PAIN MANAGEMENT
• MDR Report Key: 15940726
• Report Number: MW5113698
• Device Sequence Number: 7475135
• Product Code: HBG
• UDI-Device Identifier: 10381780263968
• UDI-Public: (01)10381780263968
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: INSHITH
• Device Lot Number: 6472614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown