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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SCD COMFORT KNEE LENGTH MED; SLEEVE, LIMB, COMPRESSIBLE
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COVIDIEN SCD COMFORT KNEE LENGTH MED; SLEEVE, LIMB, COMPRESSIBLE Back to Search Results
Model Number 74022
Medical Device Problem Code Human-Device Interface Problem (2949)
Health Effect - Clinical Code Skin Inflammation/ Irritation (4545)
Date of Event 03/03/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported when they put the sleeve on the patient's lower leg after a surgery, the skin turned red along the inner blue human print.The patient was treated with an unknown ointment.
 
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Brand Name
SCD COMFORT KNEE LENGTH MED
Common Device Name
SLEEVE, LIMB, COMPRESSIBLE
Manufacturer (Section D)
COVIDIEN
edificio b20 calle #2 zona fra
alajuela
CS 
MDR Report Key11464266
Report Number3009211636-2021-00740
Device Sequence Number19989795
Product Code JOW
UDI-Device Identifier10884521130869
UDI-Public10884521130869
Combination Product (Y/N)N
Initial Reporter CountryJA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/11/2021
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
Operator of Device No Information
Device Model Number74022
Device Catalogue Number74022
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/03/2021
Initial Report FDA Received Date03/11/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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