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

Model Number 3034-00

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

No investigation possible.Product was not sent in for evaluation.

Event Description

Pmi inc.Received a mdr information from the fda on august 11th 2017, that a mdr was filed for a product of pmi.There is no information who reported this case.No further information can be obtained."suboccipital craniotomy for tumor removal.When skull clamp removed a laceration was identified as the clamp had slipped at some point.Required staples to close wound." incident date: event date (b)(6) 2017; date fda received: 07/20/2017; date mdr received by pmi inc.: 08/11/2017; date information received by pmi complaint unit 14/11/2017.

• Brand Name: DORO® SKULL CLAMP RDL
• Type of Device: DORO® SKULL CLAMP RADIOLUCENT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger strasse 38; freiburg, 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger strasse 38; freiburg, 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger strasse 38; freiburg, 79111 ; GM 79111
• MDR Report Key: 6803044
• MDR Text Key: 82982617
• Report Number: 3003923584-2017-00032
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K032331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/11/2017

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
• Device Operator: Health Professional
• Device Model Number: 3034-00
• Device Catalogue Number: 3034-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention