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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST HUNGARY KFT COMPEED NOS

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COLOPLAST HUNGARY KFT COMPEED NOS Back to Search Results
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.
 
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Brand NameCOMPEED NOS
Type of DeviceCOMPEED
Manufacturer (Section D)
COLOPLAST HUNGARY KFT
nyirbator, szabolcs-szatmar-bereg 4300
HU 4300
MDR Report Key12474327
MDR Text Key281326020
Report Number3014660808-2021-00001
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Number of Events Reported1
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 Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/15/2021 Patient Sequence Number: 1
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