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 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the patient was not monitored frequently and it was estimated that the patient may have been checked every few hours.The alleged injury was reported as a waffle pattern of raised red marks on the patients back.The patient received an over the counter silvadene cream and dressing.The hospital tested all associated t-pumps as a result of this event and reported that all of them have passed inspection with no defects found.The serial number of the specific device being used was not recorded.The specific model of pad being used with the t-pump was also not available.It was identified by the information provided that the injury described resembles a pressure injury that was most likely associated with the pad and caused by mechanical forces.The device could not be identified.

Event Description

It was alleged that a patient received a burn while using heat therapy on the highest setting overnight following surgery.

• 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: 7287586
• MDR Text Key: 100772286
• Report Number: 0001831750-2018-00110
• 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
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2018
• 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