MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-10 for STORZ BENGER PROBE HOOK E4222 manufactured by Bausch & Lomb, Inc.
[4670187]
During tdp (tear duct probe) procedure, physician informed circulator that crochet hook in the set broke at the tip and was inside the patient's nose. After several attempts, the objects was found and removed. A follow-up x-ray was performed. This is the second event reported with this medical device at this facility within approximately 5 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 | 3928419 |
| MDR Report Key | 3928419 |
| Date Received | 2014-07-10 |
| Date of Report | 2014-07-10 |
| Date of Event | 2014-07-01 |
| Report Date | 2014-07-10 |
| Date Reported to FDA | 2014-07-10 |
| Date Reported to Mfgr | 2014-07-11 |
| Date Added to Maude | 2014-07-11 |
| 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 | 2014-07-10 |
| Model Number | E4222 |
| Catalog Number | E4222 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DAY |
| 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 | 2014-07-10 |