MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-07-21 for LACRICATH LACRIMAL DUCT CATHETER, 2.0MM LDC213 * manufactured by Quest Medical, Inc..
[509582]
The customer reported that during pre-demo preparation, he found a catheter which was partially inflated upon removal of the sleeve. It appeared to be perforated when examined under a microscope. The sample will be returned to quest for investigation. Product lot number is 24668. 03y.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00050 |
| MDR Report Key | 742740 |
| Report Source | 05 |
| Date Received | 2006-07-21 |
| Date of Report | 2006-07-20 |
| Date of Event | 2006-05-13 |
| Date Mfgr Received | 2006-05-23 |
| Device Manufacturer Date | 2005-07-01 |
| 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 | 2006-06-12 |
| Model Number | LDC213 |
| Catalog Number | * |
| Lot Number | 24668.03Y |
| ID Number | * |
| Device Expiration Date | 2007-07-13 |
| 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 | 730565 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-21 |