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

Catalog Number 8002062022

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Hyperemia (1904); Superficial (First Degree) Burn (2685)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The burn allegedly appeared as a "mild sunburn" and no treatment was required.

Event Description

It was alleged that while the patient was lying on the pad, they allegedly received a 1st degree burn from the temperature pump.

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 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
• 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: 9249438
• MDR Text Key: 172602495
• Report Number: 0001831750-2019-01198
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8002062022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1