PTFE POLYMER PLEDGETS 88868682-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-08-14 for PTFE POLYMER PLEDGETS 88868682-01 manufactured by Davis & Geck Caribe Ltd.

MAUDE Entry Details

Report Number9612501-2019-01560
MDR Report Key8893762
Report SourceFOREIGN,USER FACILITY
Date Received2019-08-14
Date of Report2019-08-14
Date Mfgr Received2019-07-25
Date Added to Maude2019-08-14
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 FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1DAVIS & GECK CARIBE LTD
Manufacturer StreetZONA FRANCA DE SAN ISIDRO
Manufacturer CitySANTO DOMINGO 0101
Manufacturer CountryDO
Manufacturer Postal Code0101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePTFE POLYMER PLEDGETS
Generic NamePATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Product CodeDXZ
Date Received2019-08-14
Model Number88868682-01
Catalog Number88868682-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDAVIS & GECK CARIBE LTD
Manufacturer AddressZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-14

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