MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-15 for LACRICATH DCP 3MM PROCEDURE KIT DCP315-UNI manufactured by Quest Medical, Inc..
[1195224]
Balloon leaked around seal and would not hold pressure enough to maintain inflation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1398643 |
| MDR Report Key | 1398643 |
| Date Received | 2009-05-15 |
| Date of Report | 2009-05-15 |
| Date of Event | 2009-03-26 |
| Report Date | 2009-05-15 |
| Date Reported to FDA | 2009-05-15 |
| Date Added to Maude | 2009-06-07 |
| 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 | LACRICATH DCP 3MM PROCEDURE KIT |
| Generic Name | CATHETER, LACRIMAL DUCT |
| Product Code | HNW |
| Date Received | 2009-05-15 |
| Returned To Mfg | 2009-04-15 |
| Model Number | NA |
| Catalog Number | DCP315-UNI |
| Lot Number | 33472 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-15 |