MAUDE Adverse Event Report: CRANIAL TECHNOLOGIES, INC. DOC BAND; CRANIAL ORTHOSIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Skull Fracture (2077)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing records confirmed that the device was manufactured to specification.Review of the provision of treatment confirmed that all standard clinical procedures were followed.Parents had routine questions throughout treatment, with these questions/concerns being addressed at each visit.The device does appear to have been taken off more frequently than advised.No one witnessed the event that led to the injury and the timeline of the injury is uncertain, so no determination has been made at this point as to whether, or what role, the device played in the reported injury.The investigation is ongoing.
Event or Problem Description
Healthy patient (minor) was in treatment with cranial orthosis for 3 months.During the treatment period, baby suffered an injury to the nose causing a blood clot (septal hematoma) requiring surgery.Mom disclosed during the next appointment that baby had surgery to address the injury on (b)(6) 2020.During this appointment, an adjustment was made to the front of the band to keep it from irritating the surgical area.Patient had two weeks of treatment left at this point, but parents canceled the exit appointment.Almost 5 weeks later, parents scheduled and came in for an exit appointment on (b)(6) 2020.During this appointment, parents reported that the baby had broken his nose and had a septal hematoma (rather than what was initially reported as a blood clot).Though they (parents) did not see the injury occur, their ent felt that the band caused the injury.Since the injury/event was not observed, and no injury was externally noticeable or identified for several days, it is not clear exactly when the injury occurred.As a result, it is not clear at this point whether the cranial orthosis was involved in causing the injury.

• Brand Name: DOC BAND
• Common Device Name: CRANIAL ORTHOSIS
• Manufacturer (Section D): CRANIAL TECHNOLOGIES, INC.; 1395 w auto dr; tempe AZ 85284
• MDR Report Key: 11032959
• Report Number: 2030829-2020-00001
• Device Sequence Number: 13767237
• Product Code: OAN
• UDI-Device Identifier: B288CRANIALHELMET0
• UDI-Public: +B288CRANIALHELMET0/$$700244080L
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K014012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: 00244080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO
• Patient Weight: 10