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

Catalog Number UNK_MED

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 11/27/2017

Event Type  Injury  

Event Description

It has been alleged that a patient was burned while using the device.Further information has not been provided.

Manufacturer Narrative

It was alleged that a patient experienced a burn while using a mul-t-pad with an associated tp700 device.The model and lot number of the pad used was not specified by the user facility.The user facility identified that the patient received a few small water blisters about the size of a pea of their back.The patients son stated that the patient had sensitive skin which may be a contributing factor to the issue.An allevyn dressing was used for protection, however, no medication was applied and the patient was discharged the same day.The associated t-pump was allegedly tested and passed the operating temperature test.A review of the information associated with this event, identified that unless there was a specific device malfunction, the burn was likely misidentified.For a burn to occur, the device 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 there must be a failure of both the backup limit thermostat and the primary thermostat (operating temperature test) in order to achieve a temperature of 44° c that would allow for a burn to occur, it is most likely that the patient experienced a soft tissue injury from the mul-t-pad that was being used.This can be attributed to mechanical forces (such as pressure or sheer) created by the pad.The device could not be identified.

Event Description

It has been alleged that a patient was burned while using the device.

Manufacturer Narrative

Supplemental submitted to include udi.The device could not be identified.

Event Description

It has been alleged that a patient was burned while using the device.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7137741
• MDR Text Key: 95476588
• Report Number: 0001831750-2017-00592
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• 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: 11/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1