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

Model Number 3034-00

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

No evaluation possible as the device was not returned.Because the customer could not allocate the exact product to the event, there are in total three mdr's generated for three possible products, although there was only one event.

Event Description

Customer service was contacted on (b)(4) 2017 from distributor.Distributor stated that she was contacted from customer on (b)(6) 2017: => customer has a clamp that needs repair.It happens during patient incident.Customer service called customer on (b)(4) 2017: event with patient involvement on (b)(6) 2017.Unknown if patient was injured.Customer stated he has 3 skull clamps but do not know which one the incident happened with.Patient being flipped prone from supine and that´s when the skull clamp slipped.".

• Brand Name: DORO® SKULL CLAMP RADIOLUCENT
• Type of Device: DORO® SKULL CLAMP RADIOLUCENT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 6892976
• MDR Text Key: 87299857
• Report Number: 3003923584-2017-00041
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2017

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: No Information
• 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: Not provided
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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