MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-13 for LACRICATH LACRIMAL DUCT CATHETER LDC315T manufactured by Quest Medical, Inc..
[80126476]
The surgical center materials manager reported an issue encountered with a lacrimal duct catheter during use. The report stated the device leaked. There were no patient complications reported as a result of the alleged issue. Another device was used to complete the procedure. The device was returned to the manufacturer for evaluation. See also 1649914-2017-00057 for first device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00061 |
| MDR Report Key | 6713215 |
| Date Received | 2017-07-13 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-06-14 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2017-07-13 |
| 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 | 3 |
| Manufacturer Contact | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LACRICATH LACRIMAL DUCT CATHETER |
| Generic Name | LACRIMAL DUCT CATHETER |
| Product Code | OKS |
| Date Received | 2017-07-13 |
| Returned To Mfg | 2017-06-16 |
| Model Number | LDC315T |
| Lot Number | 0531747M06 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-13 |