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

Catalog Number	8002062022
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hyperemia (1904); Superficial (First Degree) Burn (2685)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The burn allegedly appeared as a "mild sunburn" and no treatment was required.
Event or Problem Description
It was alleged that while the patient was lying on the pad, they allegedly received a 1st degree burn from the temperature pump.
Additional Manufacturer Narrative
After investigation, the alleged reddening of the patients skin was found to not likely be related to a defect with the product as no malfunction or product defect was alleged.A conversation with a clinical science liaison identified that this was likely reactive hyperemia related to compression force while laying on the pad.Device updated to temperature therapy pad.
Event or Problem Description
It was alleged that while the patient was lying on the pad, they allegedly received a 1st degree burn.

• Brand Name: TEMPERATURE THERAPY PAD
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 9249438
• Report Number: 0001831750-2019-01198
• Device Sequence Number: 2993344
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 8002062022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1