UNKNOWN TEDS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-30 for UNKNOWN TEDS manufactured by Covidien.

Event Text Entries

[1380225] It was reported to covidien on (b)(6) 2010 that a customer had an issue with ted stockings. The customer reports the thigh length ted stockings were applied pre-op. Postop the patient was sent to the icu where it was noticed the patient had tissue injury at the site of the elastic band on the thigh. This was on the same day as surgery. Patient's leg was re-measured and correct size confirmed. The stockings were removed and xenoderm applied to wound area.
Patient Sequence No: 1, Text Type: D, B5


[8754447] Submit date (b)(4) 2010. An investigation is currently underway; upon completion, the results wil be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1017072-2010-00024
MDR Report Key1823795
Report Source05,06
Date Received2010-08-30
Date of Report2010-08-05
Date of Event2010-05-01
Report Date2010-08-05
Date Reported to Mfgr2010-08-05
Date Mfgr Received2010-08-17
Date Added to Maude2011-02-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactJUDITH SHAW, RN
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1SENECA
Manufacturer Street14487 BLUE RIDGE BLVD.
Manufacturer CitySENECA SC 29672
Manufacturer CountryUS
Manufacturer Postal Code29672
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN TEDS
Generic NameCOMPRESSION STOCKINGS
Product CodeDWL
Date Received2010-08-30
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address14487 BLUE RIDGE BLVD. SENECA SC 29672 US 29672


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2010-08-30

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