KENDALL SCD 74022

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for KENDALL SCD 74022 manufactured by Cardinal Health.

Event Text Entries

[177376313] Sequential compression device (scd) pump flipped to foot mode on its own. Manufacturer response for scd sleeve, scd comfort knee length med (per site reporter). Thank you for contacting cardinal health regarding your experience with the scd comfort knee length med. According to the reporter, the patient experienced pump failure. This incident was reported. As a medical device manufacturer your feedback is an important part of our commitment to manufacturing and distributing high quality products. Below you will find our investigation results for the reported product complaint. Analysis summary: there were four (4) samples returned for this complaint. The samples were visually inspected. The event reported was confirmed. The evidence provided is enough to relate this event to the misuse. The sample evaluation and the visual inspection revealed that the sample showed tear on weld point and was observed the area where the air escapes. Sample showed leak during under water test. This issue has not potential patient or user harm/safety and has not results in serious adverse events, but this issue has been known to negatively impact effectiveness of product. This complaint will be used for tracking and trending purposes. Cardinal health is committed to ensuring customer satisfaction by providing products of only the highest quality. Therefore, your feedback is essential and greatly appreciated. This feedback helps us to identify areas of improvements in our ongoing quality.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9659203
• MDR Report Key: 9659203
• Date Received: 2020-02-03
• Date of Report: 2020-01-28
• Date of Event: 2019-09-12
• Report Date: 2020-01-28
• Date Reported to FDA: 2020-01-28
• Date Reported to Mfgr: 2020-02-03
• Date Added to Maude: 2020-02-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KENDALL SCD
• Generic Name: SLEEVE, LIMB, COMPRESSIBLE
• Product Code: JOW
• Date Received: 2020-02-03
• Model Number: 74022
• Catalog Number: 74022
• Lot Number: 3A100718
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 15 HAMPSHIRE STREET BUILDING 5 MANSFIELD MA 02048 US 02048

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-03