MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-04-12 for LACRICATH LACRIMAL DUCT CATHETER, 3.0MM LDC315 * manufactured by Quest Medical, Inc..
[445392]
A dr had inserted the catheter into the puncta and began inflation. The balloon leaked-tt was discovered there was a hole in the balloon end. The doctor used spare catheter from same box and lot, procedure went without further problems. No patient complications were reported. The part number of the kit is dcp315-unit, lot 25057. The part number of the device that allegedly failed is ldc315, from lot 24630. 08z. The mdr will be filed on the ldc315 code.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00021 |
| MDR Report Key | 701734 |
| Report Source | 06 |
| Date Received | 2006-04-12 |
| Date of Report | 2006-03-30 |
| Date of Event | 2006-02-17 |
| Date Mfgr Received | 2006-02-17 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2006-04-21 |
| 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 | 2006-04-12 |
| Returned To Mfg | 2006-02-28 |
| Model Number | LDC315 |
| Catalog Number | * |
| Lot Number | 24630.08X |
| ID Number | * |
| Device Expiration Date | 2007-09-30 |
| 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 | 690842 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. 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 | 2006-04-12 |