MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-09 for JONES TEAR DUCT TUBE * manufactured by Gunther Weiss Scientific Glass Blowing Co.
[15679333]
A glass tube was inserted into the tear duct under normal and routine procedure. When the physician attempted to re-position the tube, noticed the tube was broken. The physician initially had thought all the pieces were removed only to find out later that some pieces of glass remained. There was no injury to the pt, but additional surgery was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022599 |
| MDR Report Key | 346420 |
| Date Received | 2001-08-09 |
| Date of Report | 2001-08-09 |
| Date of Event | 2001-02-12 |
| Date Added to Maude | 2001-08-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JONES TEAR DUCT TUBE |
| Generic Name | GLASS TUBE |
| Product Code | HNW |
| Date Received | 2001-08-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 4 X 19MM JONES TUBE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 335737 |
| Manufacturer | GUNTHER WEISS SCIENTIFIC GLASS BLOWING CO |
| Manufacturer Address | 4380 NW SCIENCE PARK DR PORTLAND OR 97229 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-08-09 |