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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS Back to Search Results
Catalog Number 317-09-02
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
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 a set of arctic gel pads being applied, the adhesive separated from the pad. Biomed stated that had the original packing as well as the actual pads.
 
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Brand NameARCTIC GEL PADS
Type of DeviceARCTIC GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key12770124
MDR Text Key280454189
Report Number1018233-2021-07009
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-09-02
Device Lot NumberNGFT4948
Was Device Available for Evaluation? No
Date Returned to Manufacturer10/14/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/08/2021 Patient Sequence Number: 1
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