MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for STENTUBE LACRIMAL INTUBATION SET, LARGE DIAMETER LIS052 manufactured by Quest Medical, Inc..
[119035662]
Patient Sequence No: 1, Text Type: N, H10
[119035663]
Patient has had a probe and stent procedure done twice for persistent tearing, developed persistent bloody tears, not improved with steroid eye drops. Patient ultimately taken to the operating room (or) and on exploration of the lacrimal sac, there was a plastic fragment from a stent tube found in the lacrimal sac. Patient has received two sets of stents from two surgical events-one in (b)(6) 2017 and in (b)(6) 2017. Report submitted to manufacturer. Remaining stock has been removed from the or supply room as surgeon has reported that this product has had issues 'shredding. ' child pulled the stents placed in (b)(6) and (b)(6) out herself. Surgeon has had discussions with company/manufacturer and they had not had any similar complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7841621 |
| MDR Report Key | 7841621 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-07-31 |
| Report Date | 2018-08-14 |
| Date Reported to FDA | 2018-08-14 |
| Date Reported to Mfgr | 2018-09-04 |
| Date Added to Maude | 2018-09-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STENTUBE LACRIMAL INTUBATION SET, LARGE DIAMETER |
| Generic Name | LACRIMAL STENTS AND INTUBATION SETS |
| Product Code | OKS |
| Date Received | 2018-09-04 |
| Model Number | LIS052 |
| Catalog Number | LIS052 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | 1 ALLENTOWN PKWY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-04 |