MAUDE Adverse Event Report: COVIDIEN UNKNOWN TEDS

Device Problem Device Slipped (1584)

Patient Problems Bruise/Contusion (1754); Fall (1848); Inflammation (1932)

Event Date 03/21/2014

Event Type  Other  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with an unk ted stocking.The customer states that pt was wearing ted stockings and slipped on the linoleum floor in her bathroom.The pt was taken to (b)(6) for hospitalization.She was bruised all over and had muscle inflammation.Additional information was not provided.

Manufacturer Narrative

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

• Brand Name: UNKNOWN TEDS
• Type of Device: UNKNOWN TEDS
• Manufacturer (Section D): COVIDIEN; covidien manufacturing; alajuela 2010 1
• Manufacturer (Section G): COVIDIEN MANUFACTURING SOLULFONS SA; edificio 820 calle #2 zona franca; alajuela 2010 1; CS 20101
• Manufacturer Contact: lawrence rock ; 15 hampshire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 3736625
• MDR Text Key: 4221055
• Report Number: 3009211636-2014-00003
• Device Sequence Number: 1
• Product Code: DWL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/21/2014

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: 03/21/2014
• Initial Date FDA Received: 03/31/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization