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

Catalog Number 8002062026

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.3 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 3 malfunction events, where it was reported the blanket was leaking at the patient site.There was patient involvement, however there were no consequences or impacts to the patient.

Manufacturer Narrative

All 3 reported events took place at the same user facility.The facility was able to return 2 products for evaluation, but the 3rd product had been discarded.2 devices were evaluated but the issue was not confirmed; no defect or malfunction was found.

Event Description

This report summarizes 3 malfunction events, where it was reported the blanket was leaking at the patient site.There was patient involvement, however there were no consequences or impacts to the patient.

• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8554971
• MDR Text Key: 143698431
• Report Number: 0001831750-2019-00376
• 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: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• 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: VMSR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2019
• 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