MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for CRAWFORD LACRIMAL INTUBATION SET manufactured by Quest Medical, Inc.
[146360832]
The device has been returned to the manufacturing facility for evaluation. A follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[146360833]
A report was received regarding an alleged issue encountered with the lacrimal intubation set. The report states that the needle broke off on three of the devices. There were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00027 |
| MDR Report Key | 8642631 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-24 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-24 |
| 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 | EAGLE LABS |
| Manufacturer Street | 10201-A TRADEMARK ST |
| Manufacturer City | RANCHO CUCAMONGA CA 91730 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CRAWFORD LACRIMAL INTUBATION SET |
| Generic Name | LACRIMAL INTUBATION SET |
| Product Code | OKS |
| Date Received | 2019-05-24 |
| Returned To Mfg | 2019-05-03 |
| Lot Number | 70903DN |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-05-24 |