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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOPS MEDICAL ARTICLES INDUSTRIES INSTANT COOLING THERAPY WRAP; COLD REUSABLE WRAP
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TOPS MEDICAL ARTICLES INDUSTRIES INSTANT COOLING THERAPY WRAP; COLD REUSABLE WRAP Back to Search Results
Model Number TMF0362277
Device Problem Temperature Problem (3022)
Patient Problem Burn(s) (1757)
Event Date 06/29/2016
Event Type  Injury  
Event Description
On (b)(6) 2016, after working out at the gym, the end-user stopped at a store to purchase the cooling wrap.Later that evening, following appropriate directions, she wrapped the bandage around her knee, and kept it there for 20 minutes, as instructed.After she removed the wrap, she noticed a white residue on her skin.She wiped the residue off with cold water and thereafter, went to bed.During the course of the night, while attempting to sleep, the knee which had been wrapped developed severe pain and burning.On (b)(6) 2016, she went to a hospital where she was diagnosed with a chemical burn.She was referred to a burn unit, where she was treated by a burn specialist.The burn specialist is continuing to treat the end-user for the checmical burn injures she suffered.
 
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Brand Name
INSTANT COOLING THERAPY WRAP
Type of Device
COLD REUSABLE WRAP
Manufacturer (Section D)
TOPS MEDICAL ARTICLES INDUSTRIES
south hezou town
qidong city, jiangsu 22262 15
CH  2226215
MDR Report Key5908478
MDR Text Key53275715
Report Number3005182235-2016-00024
Device Sequence Number1
Product Code IME
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 08/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTMF0362277
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/26/2016
Distributor Facility Aware Date08/10/2016
Event Location Home
Date Report to Manufacturer08/26/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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