MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-23 for GLADSTONE-PUTTERMAN * manufactured by Gunther Weiss Scientific Glassblowing Co., Inc.
[1413415]
While inserting a new gladstone putterman tube in the patient's right eye, the end of the tube broke. Physician searched entire operative field for broken part. Unable to locate it and believes that it may have been suctioned up. The broken part measured 0. 5 x 1 mm in size. A new tube was placed without incident. The patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1571190 |
| MDR Report Key | 1571190 |
| Date Received | 2009-12-23 |
| Date of Report | 2009-12-23 |
| Date of Event | 2009-11-03 |
| Report Date | 2009-12-23 |
| Date Reported to FDA | 2009-12-23 |
| Date Added to Maude | 2010-01-07 |
| 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 | GLADSTONE-PUTTERMAN |
| Generic Name | LACRIMAL TUBE |
| Product Code | HNW |
| Date Received | 2009-12-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC |
| Manufacturer Address | 14640 NW ROCK CREEK ROAD PORTLAND OR 97231 US 97231 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-23 |