MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-30 for CRAWFORD * 28-0185 manufactured by Walsh Manufacturing Ltd..
[188067]
This is a pt who underwent a dacryocystorhinostomy on the right side. A lacrimal intubation set was used and about half of the wire broke off and remained in the pt's nostril. The pt will return to surgery in 10 days for removal of foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 284453 |
| MDR Report Key | 284453 |
| Date Received | 2000-06-30 |
| Date of Report | 2000-06-27 |
| Date of Event | 2000-06-23 |
| Report Date | 2000-06-27 |
| Date Added to Maude | 2000-07-06 |
| 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 | CRAWFORD |
| Generic Name | LACRIMAL INTUBATION SET |
| Product Code | HNW |
| Date Received | 2000-06-30 |
| Model Number | * |
| Catalog Number | 28-0185 |
| Lot Number | * |
| ID Number | CONTROL # K-4-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 275271 |
| Manufacturer | WALSH MANUFACTURING LTD. |
| Manufacturer Address | * ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-06-30 |