MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-06-04 for STENTUBE LIS052 manufactured by Quest Medical, Inc..
[275301]
During a bilateral dcr, a stentube was being used during intubation os (left eye). The probe pulled off the silicone tubing. The surgeon was to complete the intubation. On the od (right eye) during intubation, the probes pulled off the silicone on both ends. The surgeon was unable to use the stentube and had to complete the intubation with the crawford tubes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2003-00031 |
| MDR Report Key | 465155 |
| Report Source | 05,06 |
| Date Received | 2003-06-04 |
| Date of Report | 2003-06-04 |
| Date of Event | 2003-04-17 |
| Date Mfgr Received | 2003-04-17 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2003-06-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATHRYN THOMPSON |
| Manufacturer Street | ONE ALLENTOWN PKWY |
| 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 | STENTUBE |
| Generic Name | OPHTHALMIC INTUBATION TUBE |
| Product Code | HNL |
| Date Received | 2003-06-04 |
| Model Number | LIS052 |
| Catalog Number | LIS052 |
| Lot Number | 96134-014 |
| ID Number | * |
| Device Expiration Date | 2004-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 454099 |
| 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 | 2003-06-04 |