MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07,company representati report with the FDA on 2011-09-02 for STRUT PICK, .50MM PT.,90 DEG ANG,MED 1/E 3722062 manufactured by Medtronic Xomed Inc..
[22123497]
It was reported while undergoing an ear procedure, the tip of an oto pick instrument broke off in a patient's ear. Another magnetized instrument was used to retrieve the metal tip. No injury or sequella reported. Long term prognosis was reported as good. The customer did not know if the product broke in the outer or inner ear. It was also reported that the fragment was retrieved quickly and without difficulty.
Patient Sequence No: 1, Text Type: D, B5
[22259749]
Patient weight was not known by reporter. The customer did not have the product lot number. Instrument will not be returned to the manufacturer. An oto pick is used for a variety of ear procedures, most commonly in middle ear procedures. It is long and narrow with a very fine tip. Some picks have a slight angle at the tip for better access to the anatomy of the ear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2011-00064 |
| MDR Report Key | 2232139 |
| Report Source | 00,06,07,COMPANY REPRESENTATI |
| Date Received | 2011-09-02 |
| Date of Report | 2011-08-08 |
| Date of Event | 2011-04-12 |
| Report Date | 2011-06-09 |
| Date Reported to FDA | 2011-06-09 |
| Date Mfgr Received | 2011-08-08 |
| Date Added to Maude | 2012-06-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| 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 | STRUT PICK, .50MM PT.,90 DEG ANG,MED 1/E |
| Generic Name | PICK, MICROSURGICAL EAR |
| Product Code | JYT |
| Date Received | 2011-09-02 |
| Model Number | 3722062 |
| Catalog Number | 3722062 |
| Lot Number | NOT PROVID |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-09-02 |