MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-11-18 for WILLIAMS LACRIMAL PROBE 00-0 OP7030-300 manufactured by Allegiance Healthcare Corp.
| Report Number | 1423507-1999-00336 |
| MDR Report Key | 250935 |
| Report Source | 05,06 |
| Date Received | 1999-11-18 |
| Date of Report | 1999-11-18 |
| Date of Event | 1999-10-21 |
| Date Mfgr Received | 1999-11-12 |
| Date Added to Maude | 1999-11-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8477853309 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WILLIAMS LACRIMAL PROBE 00-0 |
| Generic Name | INSTRUMENT |
| Product Code | HNL |
| Date Received | 1999-11-18 |
| Model Number | OP7030-300 |
| Catalog Number | OP7030-300 |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 243101 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 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. Other | 1999-11-18 |