UNKNOWN TEDS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-07 for UNKNOWN TEDS manufactured by Covidien.

Event Text Entries

[3179600] It was reported to covidien on (b)(6) 2012 that a customer had an issue with a repair of ted stockings. The customer reports patient had skin irritation causing a skin ulcer. The patient was referred to the wound clinic where healing was accomplished with regular wound care. The patient had to be prescribed antibiotics during the care.
Patient Sequence No: 1, Text Type: D, B5


[10316800] An investigation is currently underway, upon completion the results will be forwarded. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1017072-2012-00014
MDR Report Key2872375
Report Source06
Date Received2012-12-07
Date of Report2012-11-08
Report Date2012-11-08
Date Reported to Mfgr2012-11-08
Date Mfgr Received2012-11-08
Date Added to Maude2013-01-03
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524970
Manufacturer G1COVIDIEN
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 NameTED
Product CodeDWL
Date Received2012-12-07
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address14487 BLUE RIDGE BLVD. SENECA SC 29672 US 29672


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-12-07

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