MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-05-06 for 5192 FRONTALIS SUSPENSION SET manufactured by Visitec.
[95507]
Performed bilateral frontalis slings using product 5192 on 10-23-97. Made adjustment to right eye on 2-13-98. On 3-18-98, dramatic ptosis was noted on right eye. Wound was opened and it was found that the sling had broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1047439-1998-00001 |
| MDR Report Key | 167216 |
| Report Source | 05 |
| Date Received | 1998-05-06 |
| Date of Report | 1998-04-28 |
| Date of Event | 1998-03-18 |
| Date Mfgr Received | 1998-04-10 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1998-05-14 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5192 FRONTALIS SUSPENSION SET |
| Generic Name | PTOSIS SLING |
| Product Code | HNM |
| Date Received | 1998-05-06 |
| Returned To Mfg | 1998-04-08 |
| Model Number | 5192 |
| Catalog Number | 5192 |
| Lot Number | 040597 |
| ID Number | * |
| Device Expiration Date | 2002-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 162713 |
| Manufacturer | VISITEC |
| Manufacturer Address | 7575 COMMERCE CT. SARASOTA FL 342433212 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. Other | 1998-05-06 |