MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for AHMED GLAUCOMA VALVE FP8 manufactured by New World Medical, Inc..
[187165881]
Device history record for the lot reported was reviewed and no issues were observed. Product was manufactured with validated procedures and all product is tested 100% prior to release. The sample was returned to new world medical on (b)(6) 2020. The device is pending evaluation for testing.
Patient Sequence No: 1, Text Type: N, H10
[187165882]
High iop and no light perception.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000125279-2020-00010 |
| MDR Report Key | 9862757 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-20 |
| 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 | CRISTINA AVALOS |
| Manufacturer Street | 10763 EDISON COURT |
| Manufacturer City | RANCHO CUCAMONGA, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4664304 |
| Manufacturer G1 | NEW WORLD MEDICAL, INC. |
| Manufacturer Street | 10763 EDISON COURT |
| Manufacturer City | RANCHO CUCAMONGA, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AHMED GLAUCOMA VALVE |
| Generic Name | GLAUCOMA SHUNT |
| Product Code | KYF |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-17 |
| Model Number | FP8 |
| Catalog Number | FP8 |
| Lot Number | G0619 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEW WORLD MEDICAL, INC. |
| Manufacturer Address | 10763 EDISON COURT RANCHO CUCAMONGA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-03-20 |