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

Catalog Number INSHITH

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/06/2022

Event Type  malfunction  

Event 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
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)
• Manufacturer (Section D): INTEGRA LIFESCIENES CORP. /INTEGRA PAIN MANAGEMENT
• MDR Report Key: 15940726
• MDR Text Key: 305244176
• Report Number: MW5113698
• Device Sequence Number: 1
• Product Code: HBG
• UDI-Device Identifier: 10381780263968
• UDI-Public: (01)10381780263968
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1