MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for STENTUBE LACRIMAL INTUBATION SET LIS052 manufactured by Quest Medical, Inc..
[85614013]
The hospital reported an issue encountered with the lacrimal intubation tube during use. The report stated that the catheter was "slipping out of the silver (delivery tube). " the report stated the physical could not get it to stay in the tube so that it could be put into place, and that this actually occurred with two devices. As a result of the alleged issue, the physician opened a 3rd stent and tied a 7-0 silk around it so that the catheter would not slide out of the delivery tube. 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 | 1649914-2017-00069 |
| MDR Report Key | 6840482 |
| Date Received | 2017-09-01 |
| Date of Report | 2017-11-07 |
| Date of Event | 2017-08-04 |
| Date Mfgr Received | 2017-08-04 |
| Device Manufacturer Date | 2017-01-03 |
| Date Added to Maude | 2017-09-01 |
| 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 | STENTUBE LACRIMAL INTUBATION SET |
| Generic Name | LACRIMAL INTUBATION SET |
| Product Code | OKS |
| Date Received | 2017-09-01 |
| Returned To Mfg | 2017-08-11 |
| Model Number | LIS052 |
| Lot Number | 0526927J02 |
| 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 | 2017-09-01 |