MAUDE Adverse Event Report: DIGNITANA INC DIGNICAP DELTA; Scalp cooling system

Model Number	900-1001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a burn on the neck.

• Brand Name: DIGNICAP DELTA
• Common Device Name: Scalp cooling system
• Manufacturer (Section D): DIGNITANA INC; 10925 estate lane w185; dallas TX 75238
• Manufacturer Contact: crista cody ; 10925 estate lane w185; dallas, TX 75238 ; 4699175555
• MDR Report Key: 22319110
• Report Number: 3012146457-2025-00004
• Device Sequence Number: 8948117
• Product Code: PMC
• UDI-Device Identifier: 00850036106005
• UDI-Public: (01)00850036106005(240)900-1001(11)220901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K19111466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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 Model Number: 900-1001
• Device Catalogue Number: 900-1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Male