MAUDE Adverse Event Report: COLOPLAST HUNGARY KFT COMPEED NOS

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This serious spontaneous incident report was received on 24 aug 2021 from a patient in the united states via compeed (b)(6) page ((b)(4)).This report involved a patient with unspecified age and gender with no reported medical history or concomitant medication.On unspecified date, the patient "wore one of compeed bandages on a hike" with no further information.On unspecified date, unspecified time latency following the application of the device, the patient reported that his/her "foot had to be amputated".At the time of reporting, the outcome of the event was not recovered.No other information was reported and no further information could be obtained as no contact details were provided.

Manufacturer Narrative

Foot amputation is unlisted for compeed.The lack of relevant information regarding the patient's medical condition, the product, the circumstances of the event and the clinical course does not permit a proper assessment of the causal relationship between compeed and the occurrence of the foot amputation.Accordingly, this case is not assessable.This assessment is final as no further information is expected.

• Brand Name: COMPEED NOS
• Type of Device: COMPEED
• Manufacturer (Section D): COLOPLAST HUNGARY KFT; nyirbator, szabolcs-szatmar-bereg 4300 ; HU 4300
• MDR Report Key: 12474327
• MDR Text Key: 281326020
• Report Number: 3014660808-2021-00001
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability