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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROMED INSTRUMENTS GMBH DORO*R (RADIOLUCENT SKULL CLAMP; HEADHOLDER
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PROMED INSTRUMENTS GMBH DORO*R (RADIOLUCENT SKULL CLAMP; HEADHOLDER Back to Search Results
Model Number 3034-00
Device Problem Difficult or Delayed Positioning (1157)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 12/14/2013
Event Type  malfunction  
Event Description
The doro rep for this customer reported on (b)(6) 2014 that there was a pt slippage and pt injury occurred with a laceration.The customer never provided a customer complaint form; therefore, we have no further description of the event.Customer returned the device to pmi for inspection on (b)(6) 2014.
 
Manufacturer Narrative
Cause: the device was never inspected as part of the annuals inspection program.Potential problems may and can go undetected.Damage to starbursts was caused by user not properly aligning starbursts prior to locking down.
 
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Type of Device
HEADHOLDER
Manufacturer (Section D)
PROMED INSTRUMENTS GMBH
boetzinger strasse 38
freiburg 7911 1
GM  79111
Manufacturer Contact
lutz babilon
boetzinger strasse 38
freiburg 79111
GM   79111
6138422242
MDR Report Key4249915
MDR Text Key4991689
Report Number3003923584-2014-00014
Device Sequence Number1
Product Code HBL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032331
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number3034-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/25/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2008
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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