MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-08-14 for LACRICATH LACRIMAL DUCT CATHETER, 2.0MM LDC213 * manufactured by Quest Medical, Inc..
[520714]
The customer reported that during a procedure, the catheters would not inflate. He tried using two different kits (a total of four catheters) and none of them would work. No patient complications were reported. The surgeon requested, that they return all units from their inventory with that same lot number. A total of four boxes will be returned (two used, and two from inventory). Product code dcp213-bi, lot number 27137. The part number of the kit is dcp213-bi. The part number of the device that allegedly failed is ldc213. The mdr will be filed on the ldc213 code lot number 26859. K08.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00074 |
| MDR Report Key | 773300 |
| Report Source | 06 |
| Date Received | 2006-08-14 |
| Date of Report | 2006-08-14 |
| Date Mfgr Received | 2006-06-05 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2006-10-27 |
| 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 | 2006-08-14 |
| Returned To Mfg | 2006-08-08 |
| Model Number | LDC213 |
| Catalog Number | * |
| Lot Number | 26859.K08 |
| ID Number | * |
| Device Expiration Date | 2009-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 761089 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Baseline Brand Name | LACRICATH 2.0MM |
| Baseline Generic Name | LACRIMAL DUCT BALLOON CATHETER |
| Baseline Model No | LDC213 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-14 |