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 2019-09-18 for CNB11, GELPOINT PATH WITH ISB, 5.5CM UNKNOWN manufactured by Applied Medical Resources.
Report Number | 2027111-2019-00592 |
MDR Report Key | 9084499 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-09-18 |
Date of Report | 2019-09-18 |
Date of Event | 2019-06-21 |
Date Mfgr Received | 2019-09-09 |
Date Added to Maude | 2019-09-18 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | WENDY KOBAYASHI |
Manufacturer Street | 22872 AVENIDA EMPRESA |
Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
Manufacturer Country | US |
Manufacturer Postal | 92688 |
Manufacturer Phone | 9497138059 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CNB11, GELPOINT PATH WITH ISB, 5.5CM |
Generic Name | ANOSCOPE AND ACCESSORIES |
Product Code | FER |
Date Received | 2019-09-18 |
Returned To Mfg | 2019-08-22 |
Model Number | CNB11 |
Catalog Number | UNKNOWN |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | APPLIED MEDICAL RESOURCES |
Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-09-18 |