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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTIC GEL PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTIC GEL PADS Back to Search Results
Device Problems Use of Device Problem (1670); Expiration Date Error (2528)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the gel peeled away from the arctic gel pad backing.The pads had been placed on the patient.The nurse confirmed the pads were expired from 2017.The pads were replaced and the patient continued therapy successfully.
 
Event Description
It was reported that the gel peeled away from the arctic gel pad backing.The pads had been placed on the patient.The nurse confirmed the pads were expired from 2017.The pads were replaced and the patient continued therapy successfully.
 
Manufacturer Narrative
The reported event confirmed as use related per the event description.No sample was returned for evaluation.It is therefore unknown if the device failed to meet specification.The device was being used for treatment at the time of the reported event.The failure mode of '1.2 incorrect product selection effect iii: product does not adhere to skin¿ with a root cause of '1.2.3 incorrect product selection- user selects expired product.¿ the lot number is unknown therefore the device history record could not be reviewed.A labeling review is not required.The product code is unknown.Although the product code is unknown, the z300-unknown arcticgel pads product labeling is found to be adequate based on past reviews.The device was not returned.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key9415747
MDR Text Key179125103
Report Number1018233-2019-07734
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2017
Was Device Available for Evaluation? No
Date Manufacturer Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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