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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UNKNOWN TEDS

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COVIDIEN UNKNOWN TEDS Back to Search Results
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.
 
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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 Key3736625
MDR Text Key4221055
Report Number3009211636-2014-00003
Device Sequence Number1
Product Code DWL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
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 Received03/31/2014
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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