MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-28 for STORZ BENGER PROBE HOOK E4222 manufactured by Bausch & Lomb, Inc.
[18573873]
Benger hook broke as physician was removing from patient's nose. It was immediately realized a part of the instrument was still in the nasal cavity. The nasal cavity was suctioned and discovered the broken piece in the suction canister contents. This is the third event reported with this medical device at this facility within approximately 6 months. Staff/physicians do not know what is causing the events to occur. The manufacturer has been notified and product has been returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3969949 |
| MDR Report Key | 3969949 |
| Date Received | 2014-07-28 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-07-03 |
| Report Date | 2014-07-28 |
| Date Reported to FDA | 2014-07-28 |
| Date Reported to Mfgr | 2014-07-31 |
| Date Added to Maude | 2014-07-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ BENGER PROBE HOOK |
| Generic Name | PROBE, LACHRYMAL |
| Product Code | HNL |
| Date Received | 2014-07-28 |
| Returned To Mfg | 2014-07-14 |
| Model Number | E4222 |
| Catalog Number | E4222 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC |
| Manufacturer Address | 1400 N. GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-28 |