MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-20 for LACRICATH manufactured by Quest Medical, Inc..
[800623]
During a balloon dacryoplasty with placement of mini-mono-ka tube a 3mm balloon was passed through the lacrimal duct and inflated x2. Upon withdraw of the balloon, there was some resistance and when it came out, the balloon had been ruptured. There was questionably a piece of the balloon was not present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005629 |
| MDR Report Key | 1002060 |
| Date Received | 2008-02-20 |
| Date of Report | 2008-02-20 |
| Date of Event | 2008-02-14 |
| Date Added to Maude | 2008-02-28 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACRICATH |
| Generic Name | LACRIMAL DUCT CATHETER |
| Product Code | HNW |
| Date Received | 2008-02-20 |
| Lot Number | 29565 Z09 |
| ID Number | REF LDC315 |
| Device Expiration Date | 2010-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 971505 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY ALLEN TX 75002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-20 |