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

Model Number 1001.001

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

No evaluation possible as the device was not returned.

Event Description

Sales was contacted on 04th june 2018 by distributor.Distributor stated that the skull clamp opened during surgery.

• Brand Name: DORO® SKULL CLAMP
• Type of Device: DORO® SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; bötzinger str. 38; freiburg, 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 8734682
• MDR Text Key: 149251346
• Report Number: 3003923584-2019-00019
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: (01)04250435506196
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2019

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: Not provided
• Initial Date FDA Received: 06/26/2019
• 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