MAUDE Adverse Event Report: COSTA RICA 3856LF TED STKG NYL T/L LL; TED STOCKING

Model Number 3856LF

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Complaint, Ill-Defined (2331); Hypoesthesia, Foot/Leg (2354)

Event Date 06/22/2013

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a ted stocking.The customer states a patient was hospitalized in a care unit for a surgery on (b)(6) 2013.The patient was wearing anti-embolic stockings in combination with a compression sequential device as recommended in prevention of thrombophlebitis.The day after the surgery, the patient presented the following symptoms: loss of sensitivity to the ankle, left footdrop due to the compression of the common peroneal nerve and hematomas in the two legs were observed subsequently.The sales rep confirmed she was never notified of this complaint and she is trying to obtain additional information with the customer.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The manufacturing lot number associated with this complaint was not provided.Without the lot number, a device history record (dhr) review could not be performed.All dhrs are reviewed for accuracy prior to product release.The complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause of this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.This information will be utilized for tracking and trending purposes to determine the need for corrective action.

• Brand Name: 3856LF TED STKG NYL T/L LL
• Type of Device: TED STOCKING
• Manufacturer (Section D): COSTA RICA; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: lawrence rock ; 15 hamphire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 4190392
• MDR Text Key: 5096075
• Report Number: 3009211636-2014-00122
• Device Sequence Number: 1
• Product Code: FQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3856LF
• Device Catalogue Number: 3856LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization