MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-07-21 for LACRICATH LACRIMAL DUCT CATHETER, 2.0MM LDC213 * manufactured by Quest Medical, Inc..
[507710]
The customer reported that during a dcp procedure, the balloon catheter leaked. They opened another kit and used the catheter from that box to finish the case without further incident. The part number of the kit is dcp213-bi. The part number of the device that allegedly failed is ldc213, the reported lot number is 26253.
Patient Sequence No: 1, Text Type: D, B5
[7787373]
Defect observed is consistent with product damage due to use conditions. Balloons are 200% inspected during assembly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2006-00048 |
| MDR Report Key | 742747 |
| Report Source | 06 |
| Date Received | 2006-07-21 |
| Date of Report | 2006-07-20 |
| Date Mfgr Received | 2006-05-17 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2006-08-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MEGAN SIMS |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACRICATH LACRIMAL DUCT CATHETER, 2.0MM |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL DILATOR |
| Product Code | HNW |
| Date Received | 2006-07-21 |
| Returned To Mfg | 2006-05-19 |
| Model Number | LDC213 |
| Catalog Number | * |
| Lot Number | 26253 |
| ID Number | * |
| Device Expiration Date | 2007-09-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 730572 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-21 |