MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-31 for STENTUBE LACRIMAL INTUBATION SET manufactured by Quest Medical, Inc.
[109782698]
The complaint sample will be evaluated and a follow up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[109782699]
A report was received regarding an alleged issue encountered during use of the stent tubes. The report states that during a procedure, while the surgeon was inserting the stent tube into a pediatric patient, he noticed the silicone was shedding or flaking in the patient's eye and he removed it. The procedure was successfully completed with another intubation device. There were no fragments left in the patient's eye and no patient complications were reported as resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
[132406382]
The complaint sample was visually inspected and the shrink tube on the device was confirmed to have peeled off. The shrink tube is made from polyethylene and heat shrunk unto the tubing and probe to provide additional binding to hold the tubing and probe together. It is not certain what may have led to the shrink tube peeling off. Friction against a sharp object may lead to the shrink tube peeling. A 24-month complaint history review was conducted and no similar complaints were seen. A dhr review was conducted and no anolmalies were identified. This incident is therefore an isolated incident and a definite root cause is unknown. Quest medical will continue to monitor complaints for trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2018-00053 |
| MDR Report Key | 7558980 |
| Date Received | 2018-05-31 |
| Date of Report | 2018-08-08 |
| Date Mfgr Received | 2018-05-15 |
| Date Added to Maude | 2018-05-31 |
| 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 | 2018-05-31 |
| Returned To Mfg | 2018-05-31 |
| Lot Number | 0505556J08 |
| 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 | 2018-05-31 |