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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP
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PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP Back to Search Results
Model Number 1001.001
Device Problem Insufficient Information (3190)
Patient Problem Laceration(s) (1946)
Event Type  malfunction  
Manufacturer Narrative
No evaluation possible as the device was not returned.
 
Event Description
Customer service was contacted on 18th december by distributor.Distributor stated: "a skull clamp slipped on a patient.The patient "does" incurred a laceration.".
 
Event Description
No additional information in this follow-up.
 
Manufacturer Narrative
This is follow-up 1: the device was received on 26th december 2018.Conducted visual and functional testing/inspection.Result: pin bores are out of specification.Besides that the device is in specification.Concerning the reported event: from our experience it is unlikely that the deviation of the pin bores has contributed to the reported event.Our experience is, that pinning technique can contribute to slippages.
 
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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
MDR Report Key8235106
MDR Text Key132778400
Report Number3003923584-2018-00068
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
PMA/PMN Number
K001808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 12/18/2018
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 Number1001.001
Device Catalogue Number1001.001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/10/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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