MEDPOR IMPLANT 80014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-08 for MEDPOR IMPLANT 80014 manufactured by Porex Surgical.

Event Text Entries

[18613224] The doctor stated that the pt received a medpor sst sphere implant in (b)(6) 2009. The doctor stated that at approx four week post op, during a follow-up exam, it was noticed that the implant had exposed. The doctor reported that in (b)(6) 2009, the medpor implant was not removed and the exposure of the implant was patched using (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[18697588] Following a review of the device history record for lot number 80014-d232m11, it was determined that all processes and test criteria are within the medpor implant finished product spec.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1057129-2009-00005
MDR Report Key1413817
Report Source05
Date Received2009-07-08
Date of Report2009-07-08
Date of Event2009-03-13
Date Mfgr Received2009-06-08
Device Manufacturer Date2008-12-13
Date Added to Maude2011-03-25
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 CodeHPZ
Date Received2009-07-08
Model NumberNA
Catalog Number80014
Lot NumberD232M11
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 2009-07-08

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