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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP; DORO SKULL CLAMP
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PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP; DORO SKULL CLAMP Back to Search Results
Model Number 1001.001
Device Problems Use of Device Problem (1670); Insufficient Information (3190); Device Handling Problem (3265)
Patient Problem Laceration(s) (1946)
Event Date 04/18/2018
Event Type  Injury  
Manufacturer Narrative
No evaluation possible as the device was not returned.
 
Event Description
Customer service was contacted on (b)(6) 2018 by distributor.Distributor stated: "our customer used this the skull clamp with mayfield pins.When they were re-positioning the patient, there was a slippage at the one pin side.The patient had a laceration when the slippage occurred".
 
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Brand Name
DORO® SKULL CLAMP
Type of Device
DORO 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
sandra untenberger
boetzinger str. 38
freiburg, baden-wuerttemberg 79111
GM   79111
MDR Report Key7640553
MDR Text Key112424184
Report Number3003923584-2018-00035
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K001808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number1001.001
Device Catalogue Number1001.001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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