MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2860000000

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Pressure Sores (2326)

Event Date 05/13/2020

Event Type  Injury  

Event Description

It was reported a patient developed bed sores while using the mattress.No information has been provided regarding the severity or treatment of the bed sores.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.

Manufacturer Narrative

It was originally reported that the treatment and severity of injury to the patient was unknown.Additional information has been provided by the user facility and b5 has been updated accordingly.

Event Description

It was reported a patient developed bed sores while using the mattress.The user facility was unable to determine the severity of the injury but were able to report a wound vac was used for treatment.

• Brand Name: ISOFLEX LAL 2860
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10139603
• MDR Text Key: 194768222
• Report Number: 0001831750-2020-00632
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 2860000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other