LAP-BAND SYSTEM C-20365

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-24 for LAP-BAND SYSTEM C-20365 manufactured by Reshape Lifesciences.

MAUDE Entry Details

Report Number3013508647-2020-00018
MDR Report Key9872100
Report SourceOTHER
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2019-10-30
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KRISTIN WIELENGA
Manufacturer Street1001 CALLE AMANECER
Manufacturer CitySAN CLEMENTE, CA
Manufacturer CountryUS
Manufacturer G1APOLLO ENDOSURGERY
Manufacturer StreetBUILDING B 13.3
Manufacturer CityALAJUELAIKE, CS, CS
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLAP-BAND SYSTEM
Generic NameADJUSTABLE GASTRIC BAND
Product CodeLTI
Date Received2020-03-24
Model NumberC-20365
Catalog NumberC-20365
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerRESHAPE LIFESCIENCES
Manufacturer Address1001 CALLE AMANECER SAN CLEMENTE, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-24

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