ARC. 2.0 SLING AE050400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-16 for ARC. 2.0 SLING AE050400 manufactured by Breg, Inc..

MAUDE Entry Details

Report Number2028253-2019-00003
MDR Report Key8903057
Date Received2019-08-16
Date of Report2019-08-15
Date of Event2019-07-10
Date Mfgr Received2019-07-19
Date Added to Maude2019-08-16
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 ContactMRS. CAROL EMERSON
Manufacturer Street2885 LOKER AVE EAST
Manufacturer CityCARLSBAD CA 92010
Manufacturer CountryUS
Manufacturer Postal92010
Manufacturer Phone7607955823
Manufacturer G1BREG, INC.
Manufacturer Street2885 LOKER AVE EAST
Manufacturer CityCARLSBAD CA 92010
Manufacturer CountryUS
Manufacturer Postal Code92010
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameARC. 2.0 SLING
Generic NameARC. 2.0 SLING
Product CodeIQI
Date Received2019-08-16
Model NumberAE050400
Catalog NumberAE050400
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBREG, INC.
Manufacturer Address2885 LOKER AVE EAST CARLSBAD CA 92010 US 92010


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-16

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