MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-21 for VISITEC 5192 * manufactured by Visitec.
[21705409]
Frontalis suspension of the right eye was performed with silicone rod supplied passing needles. Care completed and pt to recovery with well positioned lid. Approx half hour later pt noted a popping in her lid and the immediate dropping of the lid. She was taken back to surgery and it was found that the loop of silicone had broken on the med limb of the loop near the lid margin. It appeared to have just fractured. The watshy sleeve and locking stitch were in place the sling was replaced with another silicone rod, and she has had no further slippage or breakage. Now 5 weeks out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 134223 |
| MDR Report Key | 134223 |
| Date Received | 1997-11-21 |
| Date of Report | 1997-11-13 |
| Date of Event | 1997-11-06 |
| Date Facility Aware | 1997-11-07 |
| Report Date | 1997-11-13 |
| Date Reported to FDA | 1997-11-19 |
| Date Reported to Mfgr | 1997-11-19 |
| Date Added to Maude | 1997-11-25 |
| 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 | 0 |
| 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 | VISITEC 5192 |
| Generic Name | FRONTALIS SUSPENSION PTOSIS SET |
| Product Code | HNM |
| Date Received | 1997-11-21 |
| Model Number | 5192 |
| Catalog Number | * |
| Lot Number | 050996 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 131156 |
| Manufacturer | VISITEC |
| Manufacturer Address | 7575 COMMERCE CT. SARASOTA FL 342433218 US |
| Baseline Brand Name | FRONTALIS SUSPENSION PTOSIS SET |
| Baseline Generic Name | PTOSIS SET |
| Baseline Model No | 5192 |
| Baseline Catalog No | 5192 |
| Baseline ID | NA |
| Baseline Device Family | OCULOPLASTIC |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K942402 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-11-21 |