MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for VALVE IN CARTRIDGE, 9MM IBV-V9 manufactured by Spiration.
[97061363]
Once spiration receives the valve, an analysis will be conducted.
Patient Sequence No: 1, Text Type: N, H10
[97061364]
At removing of the ibv-v9 valve, a stand has been detached. The part was recovered by using a biopsy forceps and it is att. To the valve. This valve was implanted on (b)(6) 2017 at lb10. The item was given over to our mrs. (b)(6) on (b)(6) 2017 and it will be send to olympus. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004450998-2018-00001 |
| MDR Report Key | 7179648 |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-10 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-12-11 |
| Date Added to Maude | 2018-01-10 |
| 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 | CYNDY ADAMS |
| Manufacturer Street | 6675 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 425636-545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VALVE IN CARTRIDGE, 9MM |
| Product Code | OAZ |
| Date Received | 2018-01-10 |
| Returned To Mfg | 2017-12-20 |
| Model Number | IBV-V9 |
| Lot Number | W02043-01 |
| ID Number | 00896506002064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIRATION |
| Manufacturer Address | 6675 185TH AVENUE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |