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

Catalog Number UNK_MED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 01/23/2016

Event Type  Injury  

Event Description

It was reported in report reference number mw5060036 that the heating pad was applied directly to the skin.Nursing noted redness and blistering consistent with heating pad pattern.

Manufacturer Narrative

It was confirmed by the customer that this device malfunction was reported in error and that this device was not involved in the alleged event.

Event Description

It was reported in report that the heating pad was applied directly to the skin.Nursing noted redness and blistering consistent with heating pad pattern.This device event was reported in error.

• 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: 5511118
• MDR Text Key: 40697471
• Report Number: 0001831750-2016-00099
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2016
• 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