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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS Back to Search Results
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the leg pads had the gel peel off while patient under therapy on arctic sun device and also stated all the pads had a large amount of condensation including the fluid delivery line.The user changed out all the pads and had saved the pads.Currently the patient was not on arctic sun device because the family decided to withdraw care.Explained to caller, information would be sent over to field assurance team to reach out.
 
Event Description
It was reported that the leg pads had the gel peel off while patient under therapy on arctic sun device and also stated all the pads had a large amount of condensation including the fluid delivery line.The user changed out all the pads and had saved the pads.Currently the patient was not on arctic sun device because the family decided to withdraw care.Explain to caller information would be sent over to field assurance team to reach out.Per follow up via nurse (b)(6) on (b)(6) 2021, the user switched the arctic gel pads and discontinued therapy due to family request.Pads were given to bd representative mitt and could not provide serial number.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for diagnostic purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿ improper design consideration or material selection¿.The dhr review could not be performed without a lot number.The product catalog number and lot number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTICGEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
MDR Report Key11693017
MDR Text Key246246065
Report Number1018233-2021-02207
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,use
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/26/2021
Initial Date FDA Received04/20/2021
Supplement Dates Manufacturer Received06/28/2021
Supplement Dates FDA Received07/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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