MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for STENTUBE LACRIMAL INTUBATION SET LIS052 801008 manufactured by Quest Medical, Inc.
[119494832]
The device has not been received for evaluation and no additional information has been received with respect to patient impact. A follow up medwatch will be submitted if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[119494833]
A report was received regarding an alleged issue encountered during use of the lacrimal intubation set. The report states that the surgeon removed a stentube that was in pieces from a tear duct. The patient had bleeding in the tear duct after placing stentube in the eye and they found an actual piece of the stentube in the tear duct.
Patient Sequence No: 1, Text Type: D, B5
[132405207]
The complaint sample was not returned for evaluation. A dhr review was conducted and no anomalies were found. Quest medical is not privy to information on the patient's medical or physiological conditions or surgical technique employed by the surgeon. No additional information has been provided by the facility on events surrounding the incident. Based on a review of manufacturing records, the root cause of this incident is not manufacturing related. Quest medical is unable to confirm the root cause of the reported incident. Complaints will continue to be monitored for trending.
Patient Sequence No: 1, Text Type: N, H10
[132405208]
The medwatch filed by the user facility on this incident states that "the 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. Child pulled the stents placed in (b)(6) 2017 out herself. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2018-00076 |
| MDR Report Key | 7838578 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-01 |
| Date Added to Maude | 2018-08-31 |
| 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 | TOSAN ONOSODE |
| 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 | STENTUBE LACRIMAL INTUBATION SET |
| Generic Name | LACRIMAL INTUBATION SET |
| Product Code | OKS |
| Date Received | 2018-08-31 |
| Model Number | LIS052 |
| Catalog Number | 801008 |
| Lot Number | 0509836M03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-31 |