MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-30 for STORZ BENGER PROBE HOOK E4222 manufactured by Bausch & Lomb, Inc..
[22001963]
The user facility reported while the doctor was performing a tear duct procedure the probe broke inside the patient's nose. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-2014-00009 |
| MDR Report Key | 3744290 |
| Report Source | 05,06 |
| Date Received | 2014-01-30 |
| Date of Report | 2014-01-07 |
| Date of Event | 2014-01-03 |
| Date Mfgr Received | 2014-01-07 |
| Date Added to Maude | 2014-05-09 |
| 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 | SHARON SPENCER, DIR. |
| Manufacturer Street | 50 TECHNOLOGY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ BENGER PROBE HOOK |
| Generic Name | HAND HELD SURGICAL INSTRUMENT |
| Product Code | HNL |
| Date Received | 2014-01-30 |
| Returned To Mfg | 2014-01-22 |
| Catalog Number | E4222 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-30 |