MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TEMP THERAPY PAD BOX OF10; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number 8002062026

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Event Description

It was reported by the customer that the temperature therapy pad is leaking.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

A specific cause could not be determined as the product was not available for evaluation, however, previous investigations and the labeling review have shown that a likely cause is the blanket coming into contact with a sharp object.The device was not returned.

Event Description

It was reported by the customer that the temperature therapy pad is leaking.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: TEMP THERAPY PAD BOX OF10
• 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: 7365080
• MDR Text Key: 103523468
• Report Number: 0001831750-2018-00158
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 07613327261318
• UDI-Public: 07613327261318
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8002062026
• Device Lot Number: UNKNOWN4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2018
• 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