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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS KENDALL SCD; SLEEVE, LIMB, COMPRESSIBLE
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COVIDIEN MEDICAL PRODUCTS KENDALL SCD; SLEEVE, LIMB, COMPRESSIBLE Back to Search Results
Model Number 29525
Device Problem Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 06/25/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reports the unit had a cut in the power cord exposing copper wires.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
An evaluation of the scd 700 was performed for the reported condition of, ¿ the unit had a cut in the power cord exposing copper wires¿.The unit was triaged and the reported issue could not be confirmed at this time.Customer complaint broken damaged power cord is verified and has an opening, however there is no copper exposed.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
KENDALL SCD
Type of Device
SLEEVE, LIMB, COMPRESSIBLE
Manufacturer (Section D)
COVIDIEN MEDICAL PRODUCTS
building 10- no 789 puxing roa
shanghai 20111 4
CN  201114
MDR Report Key7645371
MDR Text Key112568611
Report Number3006451981-2018-00483
Device Sequence Number1
Product Code JOW
UDI-Device Identifier10884521129566
UDI-Public10884521129566
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29525
Device Catalogue Number29525
Was Device Available for Evaluation? No
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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