MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-08-14 for LARGE DIAMETER LACRIMAL INTUBATION SET/ STENTUBE LIS052 * manufactured by Quest Medical, Inc..
[520583]
The customer reported that during a procedure, while inserting the stentube, the tubing broke (in the tubing not at the metal). They used the other tube from the same box to finish the case without further incident. No patient complications were reported. The sample was saved and will be returned to quest. Product code lis052; lot number 26160.
Patient Sequence No: 1, Text Type: D, B5
[7984025]
Add'l lot # 25742. D08, exp date: 12/20/2007, device mfr date: 12/2005.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2006-00075 |
| MDR Report Key | 773275 |
| Report Source | 05,06 |
| Date Received | 2006-08-14 |
| Date of Report | 2006-08-14 |
| Date of Event | 2006-08-02 |
| Date Mfgr Received | 2006-08-02 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2006-10-27 |
| 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 | 2006-08-14 |
| Returned To Mfg | 2006-08-08 |
| Model Number | LIS052 |
| Catalog Number | * |
| Lot Number | 25529.C10 |
| ID Number | * |
| Device Expiration Date | 2007-11-23 |
| 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 | 761064 |
| 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 | 2006-08-14 |