CTR03, 5X100 KII OPT ZTHR 6/BX UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for CTR03, 5X100 KII OPT ZTHR 6/BX UNK manufactured by Applied Medical Resources.

Event Text Entries

[185725507] No product is being returned to applied medical for evaluation. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10


[185725508] Procedure performed: unknown. Event description: rep was not present for the case. Limited information available. The trocar cannula broke. There was no patient injury and the patient is fine. The device was discarded by the facility. It is unknown how the procedure was completed. When the rep reached out for additional information he was informed by the supply chain mgr that she could not find the names of the surgical team, only the doctor. The rep has already reached out to dr. [] for additional information, but [the doctor's] office is closed. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027111-2020-00443
MDR Report Key9889247
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-20
Date Mfgr Received2020-03-25
Date Added to Maude2020-03-27
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 ContactWENDY KOBAYASHI
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone9497138059
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCTR03, 5X100 KII OPT ZTHR 6/BX
Generic NameLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Product CodeGCJ
Date Received2020-03-27
Model NumberCTR03
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL RESOURCES
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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