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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 05/18/2021

Event Type  Injury  

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 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)
• Type of Device: DORO® SKULL CLAMP RADIOLUCENT (3-PIN HFD)
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: christopher schmitz ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 12016104
• MDR Text Key: 256698420
• Report Number: 3003923584-2021-00016
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435503867
• UDI-Public: 04250435503867
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K032331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other