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U.S. Department of Health and Human Services

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

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CRANIAL TECHNOLOGIES, INC. DOC BAND CRANIAL ORTHOSIS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Skull Fracture (2077)
Event Date 08/20/2020
Event Type  Injury  
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 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.
 
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Brand NameDOC BAND
Type of DeviceCRANIAL ORTHOSIS
Manufacturer (Section D)
CRANIAL TECHNOLOGIES, INC.
1395 w auto dr
tempe AZ 85284
Manufacturer Contact
jeff riggs
1395 w auto dr
tempe, AZ 85284
4804036350
MDR Report Key11032959
MDR Text Key222285471
Report Number2030829-2020-00001
Device Sequence Number1
Product Code OAN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K014012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot Number00244080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2020
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: 12/17/2020 Patient Sequence Number: 1
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