MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-11 for STENTUBE UNK LIS052 manufactured by Quest Medical, Inc..
[15265590]
When using the stentube lacrimal intubation set-large diameter, one of the tubes broke away from the inserter. Three tubes were on the field-two were used; the defective one removed. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3687367 |
| MDR Report Key | 3687367 |
| Date Received | 2014-03-11 |
| Date of Report | 2014-02-28 |
| Date of Event | 2014-01-03 |
| Report Date | 2014-02-28 |
| Date Reported to FDA | 2014-03-11 |
| Date Reported to Mfgr | 2014-03-19 |
| Date Added to Maude | 2014-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STENTUBE |
| Generic Name | LACRIMAL STENTS AND INTUBATION SETS |
| Product Code | HNL |
| Date Received | 2014-03-11 |
| Returned To Mfg | 2014-02-13 |
| Model Number | UNK |
| Catalog Number | LIS052 |
| Lot Number | 0448683S01 OR 0440663A09 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-11 |