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 |