MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-07 for EXTENDABLE FLEXTIP CANNULA 3298 manufactured by Medone Surgical, Inc..
[130626367]
Device was not returned from user, condition could not be verified. Device history record and manufacturing records do not indicate any anomalies.
Patient Sequence No: 1, Text Type: N, H10
[130626368]
User facility reported silicone tip detached from cannula. Surgeon was unable to retrieve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002865793-2018-00001 |
| MDR Report Key | 8142703 |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-10-12 |
| Device Manufacturer Date | 2018-02-06 |
| Date Added to Maude | 2018-12-07 |
| 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 | MR. PAUL BUTCHER |
| Manufacturer Street | 670 TALLEVAST ROAD |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal | 34243 |
| Manufacturer Phone | 9413593129 |
| Manufacturer G1 | MEDONE SURGICAL |
| Manufacturer Street | 670 TALLEVAST ROAD |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34243 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EXTENDABLE FLEXTIP CANNULA |
| Generic Name | CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2018-12-07 |
| Model Number | 3298 |
| Lot Number | A1812 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDONE SURGICAL, INC. |
| Manufacturer Address | 670 TALLEVAST ROAD SARASOTA FL 34243 US 34243 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-07 |