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

Catalog Number TP22G

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 02/13/2017

Event Type  malfunction  

Event Description

It was alleged that the temperature pad was leaking.

Manufacturer Narrative

The issue was not able to be confirmed as the pad was not available for evaluation.The customer disposed of the pad before it could be returned.The customer disposed of the pad before it could be returned.

Event Description

It was alleged that the temperature pad was leaking.

Manufacturer Narrative

Supplemental submitted to include udi.The customer disposed of the pad before it could be returned.

Event Description

It was alleged that the temperature pad was leaking.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6404192
• MDR Text Key: 70183525
• Report Number: 0001831750-2017-00069
• Device Sequence Number: 1
• Product Code: ILO
• 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,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: TP22G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: 02/13/2017; 02/13/2017
• Supplement Dates FDA Received: 08/01/2017; 03/23/2018
• 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