MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-25 for LACRICATH DCP315-UNI manufactured by Quest Medical, Inc.
[19054132]
Schedule for right eye tear duct probing with balloon dilation. Balloon catheter not holding pressure and replaced as per surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1095943 |
| MDR Report Key | 1095943 |
| Date Received | 2008-07-25 |
| Date of Report | 2008-07-25 |
| Date of Event | 2008-06-13 |
| Report Date | 2008-07-25 |
| Date Reported to FDA | 2008-07-25 |
| Date Added to Maude | 2008-08-06 |
| 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 |
| 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 | LACRICATH |
| Generic Name | CATHETER, BALLOON |
| Product Code | HNW |
| Date Received | 2008-07-25 |
| Model Number | DCP315-UNI |
| Catalog Number | DCP315-UNI |
| Lot Number | 32044 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1065637 |
| Manufacturer | QUEST MEDICAL, INC |
| Manufacturer Address | ONE ALLENTOWN PKWY ALLEN TX 750024211 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-25 |