MAUDE Adverse Event Report: Black Forest Medical GmbH DORO® Skull Clamp; DORO® QR3 Skull Clamp Teflon

Model Number	3003-009
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer informed us on august 4, that one of our products was involved in a case in which the patient sustained a laceration.
Additional Manufacturer Narrative
At the time of writing, the device in question had not yet been received for examination, therefore no conclusive assessment of the incident described can be provided at this time.The reporting party has been requested to provide the product and additional information regarding the reported incident.Any relevant findings will be included in a follow-up report, when applicable.

• Brand Name: DORO® Skull Clamp
• Common Device Name: DORO® QR3 Skull Clamp Teflon
• Manufacturer (Section D): Black Forest Medical GmbH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): Black Forest Medical GmbH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: julia hundertmark ; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 50586026
• Report Number: 3003923584-2026-00022
• Device Sequence Number: 13229632
• Product Code: HBL
• UDI-Device Identifier: 04250435500781
• UDI-Public: 04250435500781
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: Health Professional
• Device Model Number: 3003-009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown