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

Model Number 74022

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 06/11/2019

Event Type  Injury  

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 Description

The customer reports during surgery for colorectal cancer, compartment syndrome occurred in the patient using the scd comfort sleeve.

Manufacturer Narrative

Submit date: 18-jul-2019.Additional incident and patient information was provided on 16-jul-2019.Based on the additional information, the following sections have been updated: added available patient information in sections a2, a3, a4 and a5.Added preexisting medical conditions in section b7.Added additional incident information to section b5.

Event Description

The customer reports during surgery for colorectal cancer, compartment syndrome has occurred in the patient using the scd comfort sleeve.Additional information received on 16-jul-2019 states that the compartment syndrome was located in the right lower leg of the patient right after surgery.The sleeves were placed before surgery.The procedure lasted for 3 hours and 30 minutes and did not involve any part of the patient¿s leg.The sleeves and scd were on the patient for 3 hours and 30 minutes.Skin/extremity assessment was performed before and after surgery but not during surgery.Medical intervention required relief incision.Additional follow up treatment will be required because the wound after the relief incision surgery has not connected because of necrosis.The patient did not have any leg or skin conditions prior to use.The only measurement done prior to surgery was the length around the abdomen.The patient can walk completely.

• Brand Name: SCD COMFORT KNEE LENGTH MED
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 8711597
• MDR Text Key: 148405740
• Report Number: 3009211636-2019-00660
• Device Sequence Number: 1
• Product Code: JOW
• UDI-Device Identifier: 10884521130869
• UDI-Public: 10884521130869
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

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
• Device Operator: No Information
• Device Model Number: 74022
• Device Catalogue Number: 74022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 07/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 59