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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH SIMPLEX HV WITH GENTAMICIN US 1 PACK; SIMPLEX HV GENTAMICIN

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AAP BIOMATERIALS GMBH SIMPLEX HV WITH GENTAMICIN US 1 PACK; SIMPLEX HV GENTAMICIN Back to Search Results
Catalog Number 6195-1-001
Device Problems Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Date 11/18/2015
Event Type  malfunction  
Manufacturer Narrative
Device not returned, retain sample will.
 
Event Description
Usimplex hv with gent was mixed and took much longer than normal to set up/harden.Doctor reported nearly 30 minutes for cement to set up.
 
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Brand Name
SIMPLEX HV WITH GENTAMICIN US 1 PACK
Type of Device
SIMPLEX HV GENTAMICIN
Manufacturer (Section D)
AAP BIOMATERIALS GMBH
lagerstr.11-15
dieburg, 64807
GM  64807
Manufacturer (Section G)
AAP BIOMATERIALS GMBH
lagerstr.11-15
dieburg 64807
GM   64807
Manufacturer Contact
lydia heimann
lagerstr. 11-15
dieburg, 64807
GM   64807
071929107
MDR Report Key5337580
MDR Text Key34751434
Report Number9615014-2015-00008
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial
Report Date 12/31/2015
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? Yes
Device Operator Health Professional
Device Expiration Date11/30/2016
Device Catalogue Number6195-1-001
Device Lot Number448BC963JV
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2015
Initial Date FDA Received12/31/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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