MAUDE Adverse Event Report: COVIDIEN SCD COMFORT KNEE LENGTH MED; SLEEVE, LIMB, COMPRESSIBLE

Model Number	74022
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/28/2020
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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that a hematoma was found on the left calf of the patient after removing the sleeve from the patient when changing the patient's body position.

• 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 Key: 10535526
• Report Number: 3009211636-2020-00715
• Device Sequence Number: 372551
• Product Code: JOW
• UDI-Device Identifier: 10884521130869
• UDI-Public: 10884521130869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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 Number: 74022
• Device Catalogue Number: 74022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other