MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-18 for WILLIAMS LACRIMAL PROBE OP7030-300 manufactured by Allegiance Healthcare Corp..
[203888]
Approx 3. 5mm tip of tear duct probe broke off in pt during outpatient procedure. X-ray verified presence of piece in pt. Ent surgeon consulted for removal. Subsequent x-ray showed no evidence that the tip remained in pt following suctioning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 250928 |
| MDR Report Key | 250928 |
| Date Received | 1999-11-18 |
| Date of Report | 1999-11-03 |
| Date of Event | 1999-10-21 |
| Date Facility Aware | 1999-10-21 |
| Report Date | 1999-11-03 |
| Date Reported to Mfgr | 1999-11-03 |
| Date Added to Maude | 1999-11-24 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | WILLIAMS LACRIMAL PROBE |
| Generic Name | TEAR DUCT PROBE |
| Product Code | HNL |
| Date Received | 1999-11-18 |
| Model Number | NA |
| Catalog Number | OP7030-300 |
| Lot Number | NA |
| ID Number | SIZE 00-0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 243101 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1435 LAKE COOK ROAD DEERFIELD IL 60015 US |
| Baseline Brand Name | WILLIAMS LACRIMAL PROBE 00-0 |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | OP7030-300 |
| Baseline Catalog No | OP7030-300 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-11-18 |