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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERMOTEK INC VASCUTHERM4; VT4
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THERMOTEK INC VASCUTHERM4; VT4 Back to Search Results
Model Number 0P9PTVT400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/13/2021
Event Type  Injury  
Manufacturer Narrative
Device evaluated by user simulation for two days and no problems detected or identified.Device performed as intended.Device was then placed on auto-tester and ran through complete testing; device met and passed all specification testing.Due to the doctor prescribing cephalexin for cellulitis, we are sending the therapy wraps used by the patient to an accredited lab for bioburden testing.Will provide a follow up report we have received the results of lab testing.
 
Event Description
Post surgical complications.
 
Manufacturer Narrative
Therapy wraps used were sent to a lab for testing.The bioburden on the knee wrap for fungal and spores was higher than that of the new wraps sent for comparison, as expected.However, the recovery efficiency was inline with normal rates.
 
Event Description
Post surgical complications.
 
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Brand Name
VASCUTHERM4
Type of Device
VT4
Manufacturer (Section D)
THERMOTEK INC
1200 lakeside parkway #200
flower mound TX 75028
MDR Report Key11309341
MDR Text Key231316895
Report Number1648700-2021-00001
Device Sequence Number1
Product Code ILO
Combination Product (y/n)N
PMA/PMN Number
K061866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number0P9PTVT400
Device Catalogue Number0P9PTVT400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COMPRESSION WRAP 0P9BNDVTCA4; COMPRESSION WRAP 0P9BNDVTCA4KNEE WRAP (MED) 0P9BL.; KNEE WRAP (MED) 0P9BLFKNMR3
Patient Outcome(s) Other;
Patient Age17 YR
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