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

Catalog Number 317-05-02

Device Problems Nonstandard Device (1420); Material Separation (1562)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.

Event Description

It was reported that they bought to their attention last week that of our arctic sun pad kids were defected and were unable to unable to be used due to the adhesive being stuck to the wrong side of the pad.They asked there was any way to be reimburse or get two small kits sent to replace the defected ones we received.

Event Description

It was reported that they bought to their attention last week that of our arctic sun pad kits were defected and were unable to be used due to the adhesive being stuck to the wrong side of the pad.They asked there was any way to be reimburse or get two small kits sent to replace the defected ones we received.Per follow up via phone on 28dec2023 it was reported that there was no impact to the patient and therapy was completed.A new set of pads were used.The device did not go to biomed.They wanted information on a possible replacement of the defective gel pads.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation.A potential root cause for this type of failure could be ¿the laminating film roll was placed inverted in the laminator machine./ the hydrogel on the pad was reworked.Hydrogel or/and laminate film do not meet the specification." however, there was insufficient information to confirm this potential root cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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 bd.

• Brand Name: ARCTIC GEL PADS
• Type of Device: ARCTICGEL PADS
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18183790
• MDR Text Key: 328691760
• Report Number: 1018233-2023-08377
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGHT2063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other