MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, FLOTATION THERAPY, POWERED

Catalog Number UNK_MED

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

Patient Problem Pressure Sores (2326)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

No model or serial number was provided.

Event Description

It is alleged the patient was laying on mattress for three weeks and developed a stage 2 pressure injury.It was further reported that the patient received unknown medical care for the alleged pressure injury.

Manufacturer Narrative

The director of clinical education practice & informatics at the user facility clarified that she believed the injury to be a stage 2 pressure injury but was not certain about the severity.When asked if the patient was treated for the reported injury, she responded that there was unknown medical treatment.

Event Description

It is alleged the patient was laying on mattress for three weeks and developed a stage 2 pressure injury.It was further reported that the patient received unknown medical care for the alleged pressure injury.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, FLOTATION THERAPY, 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7491946
• MDR Text Key: 107526952
• Report Number: 0001831750-2018-00454
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 06/19/2018

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: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 06/19/2018
• 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