MEDPOR IMPLANT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-07-29 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.

Event Text Entries

[21650371] The doctor stated to a porex surgical distributor that the pt received medpor helical rim and ear base implants. The doctor stated that the implants became exposed. The doctor contacted a surgeon who has many years of experience with medpor implant placement and removal.
Patient Sequence No: 1, Text Type: D, B5


[21863847] After several attempts, we have been unable to reach the doctor since the initial report of the incident. Item and lot number information was not provided to complete an investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1057129-2009-00008
MDR Report Key1425655
Report Source08
Date Received2009-07-29
Date of Report2009-07-27
Date Mfgr Received2009-06-22
Date Added to Maude2009-08-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKENT IVERSEN
Manufacturer Street15 DART RD.
Manufacturer CityNEWNAN GA 30265
Manufacturer CountryUS
Manufacturer Postal30265
Manufacturer Phone6784791610
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDPOR IMPLANT
Generic NameFACIAL RECONSTRUCTION
Product CodeJAZ
Date Received2009-07-29
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPOREX SURGICAL
Manufacturer Address15 DART RD. NEWNAN GA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-07-29

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