MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-22 for LARGE DIAMETER LACRIMAL INTUBATION SET/STENTUBE LIS052 * manufactured by Quest Medical, Inc..
[580987]
The customer reported that the tubes broke during a procedure. Another set was used to finish the case. The sample was saved and will be returned to quest. Product code lis052; lot number 24392. 10x. (kit code dcr904-bi).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00114 |
| MDR Report Key | 790456 |
| Report Source | 06 |
| Date Received | 2006-11-22 |
| Date of Report | 2006-11-22 |
| Date of Event | 2006-09-26 |
| Date Mfgr Received | 2006-10-30 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-12-07 |
| 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 | 0 |
| Manufacturer Contact | MEGAN SIMS |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARGE DIAMETER LACRIMAL INTUBATION SET/STENTUBE |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL PROBE |
| Product Code | HNW |
| Date Received | 2006-11-22 |
| Returned To Mfg | 2006-11-07 |
| Model Number | LIS052 |
| Catalog Number | * |
| Lot Number | 24392.10X |
| ID Number | * |
| Device Expiration Date | 2007-06-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 778125 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Baseline Brand Name | STENTUBE |
| Baseline Generic Name | OPHTHALMIC INTUBATION TUBE |
| Baseline Model No | LIS052 |
| Baseline Catalog No | LIS052 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-22 |