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

Catalog Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Biocompatibility (2886)

Patient Problems Skin Discoloration (2074); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 patient showed skin swelling and slight skin discoloration on day four of therapy, all near the neck area.The patient was still in the neonatal intensive care unit due to other issues and will follow-up on current status of skin issues.Treatment was provided.But it was unknown what treatment was provided.Additional information was received from the sales rep via email on 12aug2020.The representative met with the entire neonate intensive care unit team and reviewed the data as well as their internal process.It was concluded the arctic sun did not cause harm to the patient and the culprit was registered nurse's neglecting to reposition infants in a timely manner.Their hypoxic ischemic encephalopathy (hie) protocol states repositioning q6 and (b)(6) guidelines, as well as published clinical data, clearly stated repositioning q2.The patient was noted to have ¿questionable¿ skin coloring issues during therapy but wasn¿t noticed until end of therapy provided.Completed therapy.He noted therapy was completed on the device.

Event Description

It was reported that the patient showed skin swelling and slight skin discoloration on 4th day of therapy, all near the neck area.The patient was still in the neonatal intensive care unit due to other issues and will follow-up on the current status of skin issues.The treatment was provided, but it was unknown what treatment was provided.Additional information was received from the sales rep via email on 12aug2020, the representative met with the entire neonate intensive care unit team and reviewed the data as well as their internal process.It was concluded the arctic sun did not cause harm to the patient and the culprit was registered nurse's neglecting to reposition infants in a timely manner.Their hypoxic ischemic encephalopathy (hie) protocol states repositioning q6 and national association of neonatal nurse's (nann) guidelines, as well as published clinical data, clearly stated repositioning q2.The patient was noted to have questionable skin coloring issues during therapy, but was not noticed until end of the therapy provided.Completed the therapy.They noted that the therapy was completed on the device.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to "materials that are contacting the patient¿s intact skin are not biocompatible".Resulted in bioincompatible reaction.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog number and lot number for this device was unknown.Therefore, bard was unable to determine the associated labeling to review.The information provided by bd 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 bd.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10449668
• MDR Text Key: 204250796
• Report Number: 1018233-2020-05449
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention