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, SIZE UNK * manufactured by Quest Medical, Inc..
[464155]
Dr reported that "several months ago" he had a catheter leaking at the hub. He used another catheter and was able to complete the procedure without further incident. The doctor requested that quest call the surgery center where he did the procedure. In janurary 2006, during a follow-up call, they were unable to provide any specific information and the nurse manager. Was unaware of the event. No specific code was provided (lacricath catheter). The sample was not saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00011 |
| MDR Report Key | 701289 |
| Report Source | 06 |
| Date Received | 2006-04-12 |
| Date of Report | 2006-02-08 |
| Date Mfgr Received | 2006-01-24 |
| 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, SIZE UNK |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL DILATOR |
| Product Code | HMW |
| Date Received | 2006-04-12 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 690397 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-12 |