QUANTUM TTC ESOPHAGEAL BALLOON DILATOR QD-18X8

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-19 for QUANTUM TTC ESOPHAGEAL BALLOON DILATOR QD-18X8 manufactured by Cook Endoscopy.

MAUDE Entry Details

Report Number1037905-2020-00087
MDR Report Key9729717
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-02-19
Date of Report2020-01-21
Date of Event2020-01-12
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-04-09
Date Added to Maude2020-02-19
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 ContactMS. SCOTTIE FARIOLE
Manufacturer Street4900 BETHANIA STATION RD
Manufacturer CityWINSTON-SALEM NC 27105
Manufacturer CountryUS
Manufacturer Postal27105
Manufacturer Phone3367440157
Manufacturer G1COOK ENDOSCOPY
Manufacturer Street4900 BETHANIA STATION RD
Manufacturer CityWINSTON-SALEM NC 27105
Manufacturer CountryUS
Manufacturer Postal Code27105
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameQUANTUM TTC ESOPHAGEAL BALLOON DILATOR
Generic NameKNQ, DILATOR, ESOPHAGEAL
Product CodeKNQ
Date Received2020-02-19
Returned To Mfg2020-03-02
Catalog NumberQD-18X8
Lot NumberW4200657
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK ENDOSCOPY
Manufacturer Address4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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