MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-24 for LACRICATH LACRIMAL DUCT CATHETER LDC315T manufactured by Quest Medical Inc.
[78550676]
The surgical center's material management reported an issue encountered while using the lacricath lacrimal duct catheter. The report stated that the device malfunctioned when the physician attempted to inflate the catheter's balloon. The physician stated that the device leaked fluid, so he removed the catheter and completed the procedure using a crawford tube instead. There were no patient complications reported as a result of the alleged issue. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[96748760]
The original report stated the device model to be ldc213t. Once the device was received and evaluated it was found to be model ldc315t. Device evaluation confirmed the reported complaint condition of the device leaking. Evaluation found that there was a tear in the balloon material. It is unknown where the tear originated from. There were no anomalies found in the dhr related to the reported complain condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2017-00048 |
| MDR Report Key | 6665980 |
| Date Received | 2017-06-24 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-05-25 |
| Device Manufacturer Date | 2016-11-29 |
| Date Added to Maude | 2017-06-24 |
| 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 | 2017-06-24 |
| Returned To Mfg | 2017-05-31 |
| Model Number | LDC315T |
| Lot Number | 0526186D02 |
| Device Expiration Date | 2019-11-29 |
| 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 | 2017-06-24 |