MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-17 for LACRICATH LACRIMAL BALLOON CATHETER LDC315T manufactured by Quest Medical, Inc..
[53345228]
There were no devices of the same lot as the complaint sample remaining in inventory for analysis. 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.
Patient Sequence No: 1, Text Type: N, H10
[53345229]
The physician assistant notified the manufacturer that they encountered an issue using the lacrimal balloon catheter during use. She stated the device "wasn't working properly" and had to use another one. Follow-up attempts to receive detailed information regarding the "wasn't working properly" statement were not successful. There were no patient complications reported as a result of the alleged issue. The device was returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2016-00042 |
| MDR Report Key | 5883239 |
| Date Received | 2016-08-17 |
| Date of Report | 2016-07-18 |
| Date of Event | 2016-07-18 |
| Date Mfgr Received | 2016-07-18 |
| Device Manufacturer Date | 2016-03-14 |
| Date Added to Maude | 2016-08-17 |
| 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 Phone | 9723326338 |
| 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 BALLOON CATHETER |
| Generic Name | LACRIMAL BALLOON CATHETER |
| Product Code | OKS |
| Date Received | 2016-08-17 |
| Returned To Mfg | 2016-07-21 |
| Model Number | LDC315T |
| Lot Number | 0509856M06 |
| Operator | PHYSICIAN ASSISTANT |
| Device Availability | R |
| 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 | 2016-08-17 |