MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO SKULL CLAMP RADIOLUCENT (3-PIN HFD); DORO® SKULL CLAMP RADIOLUCENT (3-PIN HFD)

Model Number	4001-20
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the device was out of specification due to wear and tear, it generally cannot be excluded that the device has contributed to the event.The interval of the supplier maintenance was exceeded for more than 8 years by the customer.The wear and tear would have been detected during annual maintenance.
Event or Problem Description
Alberta health services informed our service department on 20th of may that one of our products was involved in a case where a laceration occured.

• Brand Name: DORO SKULL CLAMP RADIOLUCENT (3-PIN HFD)
• Common Device Name: DORO® SKULL CLAMP RADIOLUCENT (3-PIN HFD)
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 12016104
• Report Number: 3003923584-2021-00016
• Device Sequence Number: 4543746
• Product Code: HBL
• UDI-Device Identifier: 04250435503867
• UDI-Public: 04250435503867
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: 4001-20
• Device Catalogue Number: 4001-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/17/2021
• 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