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

Catalog Number 2800100997

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

Patient Problem Tissue Breakdown (2681)

Event Date 02/25/2014

Event Type  Injury  

Event Description

It was reported by the user facility that the patient's skin allegedly broke down while on the mattress.

Event Description

It was reported by the user facility that the patient's skin allegedly broke down while on the mattress.

Manufacturer Narrative

Follow-up submitted with evaluation results which determined the mattress performed to specifications and no defect was found.

Manufacturer Narrative

Follow-up submitted with corrected evaluation results as investigation determined the allegation of a pressure ulcer development was due to a mattress gel issue.Mattress was replaced.

Event Description

It was reported by the user facility that the patient's skin allegedly broke down while on the mattress.

• Brand Name: ISOFLEX MEDSURG MATTRESS MODEL
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3695974
• MDR Text Key: 4500754
• Report Number: 0001831750-2014-02597
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2014

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: Other
• Device Catalogue Number: 2800100997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/23/2014; 06/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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