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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH SIMPLEX HV US; SIMPLEX HV BONE CEMENT
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AAP BIOMATERIALS GMBH SIMPLEX HV US; SIMPLEX HV BONE CEMENT Back to Search Results
Model Number SIMPLEX HV US
Device Problems Difficult to Open or Remove Packaging Material (2922); Failure To Unwrap (2940); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2014
Event Type  malfunction  
Event Description
Nurse tried to open simplex but it malfunctioned.
 
Manufacturer Narrative
When the notification of this event had been reported the initial assessment of this event by aap was "not fda reportable" because no further info was available and no surgical delay was reported.On (b)(6) 2014 pictures of the damaged package were delivered and evaluated as "fda-reportable".
 
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Brand Name
SIMPLEX HV US
Type of Device
SIMPLEX HV BONE CEMENT
Manufacturer (Section D)
AAP BIOMATERIALS GMBH
lagerstr 11-15
dieburg 6480 7
GM  64807
Manufacturer Contact
lydia heimann
lagerstr 11-15
dieburg 64807
GM   64807
MDR Report Key4349654
MDR Text Key5174215
Report Number9615014-2014-00006
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSIMPLEX HV US
Device Catalogue Number6194-1-001
Device Lot Number327 AA877EU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/25/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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