MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-12-29 for VISITEC 5192 * manufactured by Visitec Co..
[16764779]
Frontalis suspension of the right was performed with silicone rod on supplied passing needles - care completed and pt to recovery with well positioned lid. Approx 1/2 hr 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 medial limb of the loop near the lid margin - it appeared to have just fractured. The watsky 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 wk out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1047439-1997-00001 |
| MDR Report Key | 141655 |
| Report Source | 06 |
| Date Received | 1997-12-29 |
| 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 Mfgr Received | 1997-12-08 |
| Device Manufacturer Date | 1996-09-01 |
| Date Added to Maude | 1998-01-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISITEC 5192 |
| Generic Name | FRONTALIS SUSPENSION PTOSIS SET |
| Product Code | HNM |
| Date Received | 1997-12-29 |
| Model Number | 5192 |
| Catalog Number | * |
| Lot Number | 050996 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 131156 |
| Manufacturer | VISITEC CO. |
| 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 | 1997-12-29 |