MAUDE Adverse Event Report: COSTA RICA UNKNOWN TEDS; TED STOCKING

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Ulcer (2274)

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with an unknown ted stocking.The customer states that an (b)(6) year old patient has a deep decubitus (ulcer) at popliteal fossa (knee pit) due to teds.The patient was fitted correctly per nurse.No additional information was provided.

Manufacturer Narrative

Submit date:60 9/19/2014.An investigation is currently on the way.Upon completion, the results will be forwarded.

Event Description

This complaint has not been confirmed.The complaint sample was not returned to the manufacturing site for review.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.Without the sample and lot number, 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.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.A capa is not deemed necessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: UNKNOWN TEDS
• 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; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: lawrence rock ; 15 hampshire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 4101412
• MDR Text Key: 4759269
• Report Number: 3009211636-2014-00084
• Device Sequence Number: 1
• Product Code: DWL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2014

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 18 YR