MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-04-09 for MICROFRANCE? INSTRUMENT 7718 manufactured by Xomed Microfrance Mfg.
[5732023]
It was reported that the instrument broke after a few uses. Requests for additional information have been made with no response received. There was no injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[13205537]
No known impact or consequence to patient ; material fragmentation. The device has not been returned. Therefore, an analysis cannot be performed. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[35369018]
Correction. Conclusion: device not returned.
Patient Sequence No: 1, Text Type: N, H10
[102626709]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2015-00031 |
| MDR Report Key | 4673995 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-04-09 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-03-17 |
| Date Mfgr Received | 2015-06-15 |
| Device Manufacturer Date | 2013-09-26 |
| Date Added to Maude | 2015-05-08 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROFRANCE? INSTRUMENT |
| Generic Name | LOOP, WIRE |
| Product Code | JYQ |
| Date Received | 2015-04-09 |
| Model Number | 7718 |
| Catalog Number | 7718 |
| Lot Number | 130902 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MICROFRANCE MFG |
| Manufacturer Address | SAINT-AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-09 |