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 FP7 manufactured by New World Medical, Inc.
[187165993]
The doctor returned an explanted valve to new world medical. Nwm has contacted customer to obtain further information evaluation of sample returned is pending receipt of information from dr.
Patient Sequence No: 1, Text Type: N, H10
[187165994]
Customer returned explanted valve. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000125279-2020-00011 |
| MDR Report Key | 9862673 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| 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 | 2020-02-28 |
| Model Number | FP7 |
| Catalog Number | FP7 |
| Lot Number | NOT PROVIDED |
| 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. Required No Informationntervention | 2020-03-20 |