MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-20 for STENTUBE LACRIMAL INTUBATION SET LIS052 manufactured by Quest Medical, Inc..
[78020197]
The surgery center reported an issue with the stentube lacrimal intubation device during use. The surgeon reported that of three (3) devices they used, they "just fell apart" during use. There was no additional details provided other than they were from the same lot. There were no patient complications reported as a result of the alleged issue. The actual devices were not returned for evaluation; however, one remaining device from the same lot was returned to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00049 |
| MDR Report Key | 6656085 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-20 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-05-23 |
| Device Manufacturer Date | 2017-01-17 |
| Date Added to Maude | 2017-06-20 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| 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 | 2017-06-20 |
| Returned To Mfg | 2017-06-01 |
| Model Number | LIS052 |
| Lot Number | 052858 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2017-06-20 |