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

Catalog Number	UNK_MED
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Burn, Thermal (2530)
Date of Event	06/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient allegedly received a burn to their lower back.Further information was not provided.
Additional Manufacturer Narrative
It was reported that the injury was a 1st & 2nd degree burn with a pattern of the pad (8-10 circular wounds in a geometric grid).Testing on the returned concomitant t-pump unit was performed where it was identified that the temperature of the unit did not fluctuate outside of the acceptable range.A senior manager clinical science liaison was contacted, who identified based on the reported information that this was most likely not a burn, and was instead a pressure injury as a result of the temperature therapy pad.The injury was treated with daily dressing changes and ointment.Device not returned.
Event or Problem Description
It was reported that the patient allegedly received a pressure injury to their lower back during use of the temperature therapy pad.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: 8818417
• Report Number: 0001831750-2019-00610
• Device Sequence Number: 2541154
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/19/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1