MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-18 for BENGER PROBE HOOK * E-4222 manufactured by Bausch & Lomb, Inc..
[14879496]
A new instrument set was being used on a procedure. The tip of the instrument broke off in the patient's nose during the procedure. The patient's nose was suctioned out and the piece of the instrument was found in the suction canister.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3638680 |
| MDR Report Key | 3638680 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-02-18 |
| Date of Event | 2014-01-03 |
| Report Date | 2014-02-18 |
| Date Reported to FDA | 2014-02-18 |
| Date Reported to Mfgr | 2014-02-21 |
| Date Added to Maude | 2014-02-21 |
| 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 | BENGER PROBE HOOK |
| Generic Name | PROBE, LACHRYMAL |
| Product Code | HNL |
| Date Received | 2014-02-18 |
| Returned To Mfg | 2014-01-09 |
| Model Number | * |
| Catalog Number | E-4222 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DAY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | 3365 TREE CT. INDUSTRIAL BLVD SAINT LOUIS, MO 63122 MO 63122 US 63122 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-18 |