MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-31 for LACRICATH LACRIMAL DUCT CATHETER LDC213T manufactured by Quest Medical, Inc..
[85306845]
The device was returned for evaluation. An inflator was used to attempt to inflate the device to 8atm; however, the device would not inflate. Visual examination of the balloon portion of the device confirmed a tear where the balloon attaches to the hypotube. The cause of the tear is unknown. The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition. Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[85306846]
The hospital materials coordinator reported an issue encountered with the 2mm lacricath device during use. The report stated that during a procedure the balloon on the end of the stent once inflated did not hold after insertion. 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
| Report Number | 1649914-2017-00074 |
| MDR Report Key | 6833393 |
| Date Received | 2017-08-31 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-22 |
| Date Mfgr Received | 2017-06-22 |
| Device Manufacturer Date | 2016-07-14 |
| Date Added to Maude | 2017-08-31 |
| 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 | 2017-08-31 |
| Model Number | LDC213T |
| Lot Number | 0517986U08 |
| Device Expiration Date | 2019-07-14 |
| Operator | PHYSICIAN |
| Device Availability | * |
| 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 | 2017-08-31 |