MAUDE Adverse Event Report: EHOB INC. WAFFLE HEEL PROTECTORS; PROTECTOR, SKIN PRESSURE

Model Number 345CX

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

Patient Problem Ulcer (2274)

Event Date 06/04/2023

Event Type  Injury  

Event Description

The patient developed left posterior heel decubitis ulcer on the left heel potentially due to the waffle boot that the patient was wearing.

• Brand Name: WAFFLE HEEL PROTECTORS
• Type of Device: PROTECTOR, SKIN PRESSURE
• Manufacturer (Section D): EHOB INC.; indianapolis IN 46222
• MDR Report Key: 17143564
• MDR Text Key: 317477098
• Report Number: MW5118434
• Device Sequence Number: 1
• Product Code: FMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 345CX
• Device Catalogue Number: 3450CXXX010
• Device Lot Number: 23491BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Hispanic
• Patient Race: White