BATRIK SOFTPACK ANTI-FOG SOLUTION W/SPONGE 99-GOLFF

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-14 for BATRIK SOFTPACK ANTI-FOG SOLUTION W/SPONGE 99-GOLFF manufactured by Aspen Surgical Products, Caledonia.

MAUDE Entry Details

Report Number1836161-2020-00003
MDR Report Key9586569
Report SourceDISTRIBUTOR
Date Received2020-01-14
Date of Report2019-12-19
Date of Event2019-12-19
Date Mfgr Received2019-12-19
Date Added to Maude2020-01-14
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 ContactMR. JORDAN HACKERT
Manufacturer Street6945 SOUTHBELT DR. S.E.
Manufacturer CityCALEDONIA MI 49316
Manufacturer CountryUS
Manufacturer Postal49316
Manufacturer Phone6165367508
Manufacturer G1SAME AS ABOVE
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBATRIK SOFTPACK ANTI-FOG SOLUTION W/SPONGE
Generic NameANTI-FOG
Product CodeOCT
Date Received2020-01-14
Model Number99-GOLFF
Lot Number209158
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASPEN SURGICAL PRODUCTS, CALEDONIA
Manufacturer Address6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-14

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