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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; SIMPLEX HV GENTA, SIMPLEX HV
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AAP BIOMATERIALS GMBH SIMPLEX HV WITH GENTAMICIN US 1 PACK, SIMPLEX; SIMPLEX HV GENTA, SIMPLEX HV Back to Search Results
Catalog Number 6195-1-001, 619-1-0
Device Problems Difficult to Insert (1316); Off-Label Use (1494); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2015
Event Type  malfunction  
Event Description
The sales rep was made aware that the material, mgr reported, after mixing the cement, it had a glue like texture and took longer than prescribed to start to set.Once it started to harden, it set so quickly that there was almost no time to apply it.The cement was used and the case completed successfully.
 
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Brand Name
SIMPLEX HV WITH GENTAMICIN US 1 PACK, SIMPLEX
Type of Device
SIMPLEX HV GENTA, SIMPLEX HV
Manufacturer (Section D)
AAP BIOMATERIALS GMBH
dieburg
GM 
Manufacturer Contact
lydia heimann
lagerstr 11-15
dieburg 64807
GM   64807
071929107
MDR Report Key4729734
MDR Text Key20146472
Report Number9615014-2015-00002
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2015
Device Catalogue Number6195-1-001, 619-1-0
Device Lot Number347BA948IU, 424AA856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
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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