MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX 35X84 DARTEX W/FB; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2800100000

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 10/11/2017

Event Type  Injury  

Event Description

It was reported that there were an increase in pressure injuries related to the use of this mattress.No details were given regarding the severity of the injuries, or any necessary medical intervention.

Manufacturer Narrative

No device malfunctions or defects were alleged.Additionally, no specific instances of pressure injuries were reported in association with the device, only a general increase in pressure injures.Customer did not record serial number of unit, therefore no evaluation could be performed.

Event Description

It was reported that there were an increase in pressure injuries related to the use of this mattress.No details were given regarding the severity of the injuries, or any necessary medical intervention.

• Brand Name: ISOFLEX 35X84 DARTEX W/FB
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7007966
• MDR Text Key: 91290635
• Report Number: 0001831750-2017-00505
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

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?: No
• Device Operator: No Information
• Device Catalogue Number: 2800100000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 04/09/2018
• 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