MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 30; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 1704034300

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

Patient Problem Injury (2348)

Event Date 07/31/2018

Event Type  malfunction  

Event Description

It was reported that a user was allegedly injured while transferring the mattress.Further injury details were not provided.

Manufacturer Narrative

Upon further communication with the user facility, it was identified that were no occurrences of any injuries for this issue.This complaint was generated in error.No device problem occurred.

Event Description

It was reported that a user was allegedly injured while transferring the mattress.

• Brand Name: ULTRA COMFORT, SE 4 X 30
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• 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: 7805260
• MDR Text Key: 117877023
• Report Number: 0001831750-2018-00991
• Device Sequence Number: 1
• Product Code: IKY
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1704034300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 12/11/2018
• 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