MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® QR3 SKULL CLAMP

Model Number 1001.001

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

No evaluation possible as the device was not returned.

Event Description

Customer stated on 18th of march, 2020: "fail in the locking mechanism, the patient was harmed with a large laceration.".

• Brand Name: DORO® QR3 SKULL CLAMP
• Type of Device: DORO® QR3 SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; bötzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: benjamin senger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 9973370
• MDR Text Key: 188140671
• Report Number: 3003923584-2020-00010
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1