MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-03-06 for XOMED? INSTRUMENTS 3722071 manufactured by Medtronic Xomed, Inc..
[5557173]
It was reported that during a procedure, the fine tip of the product broke off into the patient. She stated the fragment was picked up? Pretty easily? And removed from the patient. There was no injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[13024727]
(b)(6). (b)(4). The product analysis indicates that the tip was broken off. The fragment was also returned. There was no evidence of any material defects that would have resulted in the break. The most likely cause of the reported event is misuse/user error. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00066 |
| MDR Report Key | 4576287 |
| Report Source | 05,06,07 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-11 |
| Date of Event | 2015-01-11 |
| Date Mfgr Received | 2015-02-11 |
| Date Added to Maude | 2015-04-07 |
| 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 | 0 |
| Event Location | 0 |
| 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 | XOMED? INSTRUMENTS |
| Generic Name | PICK, MICROSURGICAL EAR |
| Product Code | JYT |
| Date Received | 2015-03-06 |
| Returned To Mfg | 2015-02-17 |
| Model Number | 3722071 |
| Catalog Number | 3722071 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-06 |