MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-02 for STENTUBE LACRIMAL INTUBATION SET manufactured by Quest Medical, Inc.
[101481350]
The device was not returned for evaluation. A dhr review was conducted on the reported complaint lot and no anomalies were found. The manufacturing process for this device includes checks for pull force per aql sampling plan. The recorded pull forces for the lot complained about were found to be consistent and within specification of < 1. 0lbs. The root cause for the alleged issue is unknown. Quest medical will continue to monitor complaint trends for the alleged issue.
Patient Sequence No: 1, Text Type: N, H10
[101481351]
A report was received regarding an alleged issue encountered during use of the stent tubes. The report states that the lots received are breaking. There were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2018-00024 |
| MDR Report Key | 7311419 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-02 |
| Date of Report | 2018-03-02 |
| Date Mfgr Received | 2018-02-07 |
| Date Added to Maude | 2018-03-02 |
| 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 | 3 |
| Brand Name | STENTUBE LACRIMAL INTUBATION SET |
| Generic Name | LACRIMAL INTUBATION SET |
| Product Code | OKS |
| Date Received | 2018-03-02 |
| Lot Number | 0546427C03 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2018-03-02 |