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

Catalog Number 8001061550

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 04/14/2017

Event Type  Injury  

Manufacturer Narrative

Supplemental submitted to include udi. Device not returned.

Event Description

It was reported that allegedly a patient developed stage 2 pressure ulcers on the upper ankle area from the rapkit leg pads.

Event Description

It was reported that allegedly a patient developed stage 2 pressure ulcers on the upper ankle area from the rapkit leg pads.

Manufacturer Narrative

No further information regarding the alleged injury was made available. The account manager provided in servicing on the use of the pads.

Event Description

It was reported that allegedly a patient developed stage 2 pressure ulcers on the upper ankle area from the rapkit leg pads.

• Brand Name: SM/M 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: 6560257
• MDR Text Key: 108002078
• Report Number: 0001831750-2017-00191
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

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: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 8001061550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/14/2017
• 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