MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-02-07 for LACRICATH LACRIMAL DUCT CATHETER, 3.0MM LDC315 * manufactured by Quest Medical, Inc..
[21627147]
During a procedure, it was discovered that bothe catheters leaded at the hub. Another set of catheters were used to complete the procedure without any complications. The complaint samples were saved and will be returned to quest for evaluation. The device is packaged in a kit. The part number of the kit is dcp315-bi, lot 24907. The part number of the device that allegedly failed is lds315, lot unknown at this time (four potential lots went into the kit). The mdr will be filed on the ldc315 code.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00006 |
| MDR Report Key | 680862 |
| Report Source | 06 |
| Date Received | 2006-02-07 |
| Date of Event | 2005-12-05 |
| Date Mfgr Received | 2005-12-05 |
| Date Added to Maude | 2006-03-03 |
| 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 | KATHRYN JAYNE |
| 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, 3.0MM |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL DILATOR |
| Product Code | HMW |
| Date Received | 2006-02-07 |
| Returned To Mfg | 2006-01-06 |
| Model Number | LDC315 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| 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 | 670133 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US |
| Baseline Brand Name | LACRICATH LACRIMAL DUCT CATHETER, 3.0MM |
| Baseline Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT LACRYMAL DILATOR |
| Baseline Model No | LDC315 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-07 |