MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO COMFRTGL,W/BX,W/FB80X35X7,INTL; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2850000012

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

Patient Problem Ulcer (2274)

Event Date 02/11/2019

Event Type  Injury  

Event Description

It was reported that within a few hours, there was a decubitus ulcer development on the heel and ankle of a patient.Further information is not available at this time.

Manufacturer Narrative

It was reported that within a few hours, there was a decubitus ulcer development on the heel and ankle of a patient.The patient was alleged to be on the surface for 6 days and was turned to approximately 12 positions within 24 hours.The patient was alleged not to have any pre-existing conditions that would have caused or contributed to the injury.The patient was given a score of 13 on the norton scale.It was noted that a score of 25 and lower indicates a pressure ulcer risk.The patient was diagnosed with a decubitus stage 1 ulcer showing non-irritable redness of the skin and was treated with mipilex border (over the counter foam dressing) for skin protection.There were no defects alleged with the mattress.It is unknown if the product met specifications as the product was not evaluated by a stryker representative.However, with the alleged condition the product would meet specifications as there were no defects alleged with the product.After investigation, the cause for the stage 1 pressure injury was found to not likely be related to a defect with the product.The patient's low norton score may have attributed to the deterioration of the patient's skin.No device problem alleged.

Event Description

It was reported that within a few hours, there was a decubitus ulcer development on the heel and ankle of a patient.

• Brand Name: COMFRTGL,W/BX,W/FB80X35X7,INTL
• 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: 8361286
• MDR Text Key: 136868331
• Report Number: 0001831750-2019-00272
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

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: 2850000012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2018
• 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