MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LG RAPR-ROUND KIT SYSTEM, THERMAL REGULATING

Catalog Number 8001061560

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

Supplemental submitted to include udi. Not available for further evaluation.

Event Description

It was alleged by the customer that the patient formed blisters once they were put on the rap kit. Information about set temperature or mode was not known. The blisters did not appear to be friction related, they appeared to be water blisters in a pattern that matched the pattern on the wrap. There was no excessive moisture on the skin and the skin condition was checked every two hours.

Event Description

It was alleged by the customer that the patient formed blisters once they were put on the rap kit. Information about set temperature or mode was not known. The blisters did not appear to be friction related, they appeared to be water blisters in a pattern that matched the pattern on the wrap. There was no excessive moisture on the skin and the skin condition was checked every two hours.

Manufacturer Narrative

The device was not available for further evaluation. A review of the device manual identified that a potential cause as to why the patient had developed blisters may have been a use error related to not checking the patient's skin at frequent enough intervals or not properly evaluating the patient's skin condition prior to applying the device.

Event Description

It was alleged by the customer that the patient formed blisters once they were put on the rap kit. Information about set temperature or mode was not known. The blisters did not appear to be friction related, they appeared to be water blisters in a pattern that matched the pattern on the wrap. There was no excessive moisture on the skin and the skin condition was checked every two hours.

• Brand Name: LG RAPR-ROUND KIT
• Type of Device: SYSTEM, THERMAL REGULATING
• 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: 6673182
• MDR Text Key: 108006347
• Report Number: 0001831750-2017-00274
• Device Sequence Number: 1
• Product Code: DWJ
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 8001061560
• Device Lot Number: UNKNOWN1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/30/2017
• 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