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

Catalog Number UNK_MED

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 05/19/2020

Event Type  Injury  

Event Description

It was alleged that the patient was burned while using the device at home.Further information has not been provided at this time.

Manufacturer Narrative

The cause for the alleged burn could not be determined as no specific malfunction was alleged and no further information was available.Attempts to contact the customer were made to gather further information regarding this alleged issue, however, the customer did not respond to these attempts.

Event Description

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

• 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
• MDR Report Key: 10158826
• MDR Text Key: 195294603
• Report Number: 0001831750-2020-00633
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other