MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number UNK_MED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/26/2017

Event Type  Injury  

Event Description

It was alleged that a patient developed blisters on their legs during use of the device.The customer alleges that nursing staff were present at the time of the incident.

Manufacturer Narrative

The customer reported that there was no malfunction with the product and tested the unit which revealed no defects.Although there were no defects found with the product, a review of previous similar complaints, and the operations manual identified that a potential cause as to why the patient had been blistered may be attributed to the patient not being regularly checked and monitored.The customer was provided feedback on proper monitoring of the patient during use.Device was not returned.

Event Description

It was alleged that a patient developed blisters on their legs during use of the device.The customer alleges that nursing staff were present at the time of the incident.

Manufacturer Narrative

A review of the event information identified that unless there was a specific product malfunction, the burn was likely misidentified.For a burn to occur, the product would need to be at least 44° c.Without a failure of the backup and primary thermostats, the highest temperature the t-pump can reach is 42° c.As such, it is likely that the injury was misidentified by the customer.This injury was most likely a soft-tissue injury.This can be attributed to mechanical forces (such as pressure or sheer) created by the mul-t-pad.

Event Description

It was alleged that a patient developed blisters on their legs during use of the device.The customer alleges that nursing staff were present at the time of the incident.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6839695
• MDR Text Key: 84613954
• Report Number: 0001831750-2017-00374
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1