MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-08 for LACRICATH LDC213 * manufactured by Atrion Medical Products [inc.].
[16397660]
Lacricath duct catheter did not deflate completely causing difficulty in the procedure. The md was able to complete the procedure despite a defect in this single use product. Surgeon states no complications due to device malfunction. [it is not known if the problem was with the balloon, the device that locks and switches from inflate to deflate, or the vacuum device. And, it's unknown if the physician was able to inflate and deflate the balloon enough to complete all the intermediate parts of the procedure. The device was saved and sent back to the manufacturer. All other devices with the same lot number were pulled from the shelves and also returned to the manufacturer. The quality control representative from the manufacturer contacted the physician after the incident. ]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 488845 |
| MDR Report Key | 488845 |
| Date Received | 2003-10-08 |
| Date of Report | 2002-12-01 |
| Date of Event | 2002-09-01 |
| Date Added to Maude | 2003-10-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACRICATH |
| Generic Name | [LACRIMAL] DUCT CATHETER |
| Product Code | HNW |
| Date Received | 2003-10-08 |
| Model Number | LDC213 |
| Catalog Number | * |
| Lot Number | AM031302-1 |
| ID Number | * |
| Device Availability | R |
| Device Age | UNK |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 477667 |
| Manufacturer | ATRION MEDICAL PRODUCTS [INC.] |
| Manufacturer Address | 1 ALLENTOWN PKWY ALLEN TX 75002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-08 |