MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE CONTROL UNIT MODEL 1000; PATIENT WARMING DEVICE

Model Number 01000-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Ulcer (2274); Skin Tears (2516)

Event Date 09/18/2012

Event Type  Injury  

Event Description

A review of the maude database identified the following event."the patient has multiple blisters on left upper back from the kimberly clark warming pads used in the or.One blister broke and then others as well.The wound has extended to skin tears around the blister areas.This skin ulcer was most likely caused by a combination of a pressure device behind his back in the operating room for positioning as well as a heating blanket.Wound nurse consulted.".

Manufacturer Narrative

There is no information provided regarding the return of the actual complaint product to the manufacturer.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Kimberly-clark has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the kimberly-clark complaint database and identified as (b)(6).Device not returned by customer.

• Brand Name: CONTROL UNIT MODEL 1000
• Type of Device: PATIENT WARMING DEVICE
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge road; roswell GA 30076
• Manufacturer (Section G): MEDIVANCE, INC.; 321 south taylor avenue; suite 200; louisville CO 80027
• Manufacturer Contact: lisa clark ; 1400 holcomb bridge road; roswell, GA 30076
• MDR Report Key: 4104016
• MDR Text Key: 4698339
• Report Number: 1033422-2014-00025
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: PK033021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 01000-01
• Device Catalogue Number: 991094765
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention