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

Catalog Number UNK_MED

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problems Pressure Sores (2326); Burn, Thermal (2530)

Event Date 06/23/2019

Event Type  Injury  

Event Description

It was reported that the patient allegedly received a burn to their lower back.Further information was not provided.

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 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
• 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: 8818417
• MDR Text Key: 152024003
• Report Number: 0001831750-2019-00610
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• 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
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2019
• 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