MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PAD - NEONATAL CAP FOR EXPORT ONLY; NEONATAL HEAD CAP PAD

Catalog Number 31800

Device Problem Component Missing (2306)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

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 band for fixing the head was missing when the package was opened.

Event Description

It was reported that the band for fixing the head was missing when the package was opened.

Manufacturer Narrative

The reported event was inconclusive as no sample returned for evaluation.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.A potential root cause for this failure mode could be due to operator error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.H11: section a through f - 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.H3 other text: the device was not returned.

• Brand Name: ARCTICGEL PAD - NEONATAL CAP FOR EXPORT ONLY
• Type of Device: NEONATAL HEAD CAP PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11236648
• MDR Text Key: 228889906
• Report Number: 1018233-2021-00157
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 31800
• Device Lot Number: NGEN0548
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other