MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-12-18 for 5192 FRONTALIS SUSPENSION SET manufactured by Becton Dickinson.
[21608399]
A bilateral (both eyes) frontalis sling was performed on an infant with congenital ptosis using visitec product 5192 (lot 021098), frontalis suspension set. On post-operative day one, the infant had an excellent post-operative appearance. However, on post-operative day three, the mother noted that the left eye lid had dramatically changed positions. When examined, it was concluded that the ptosis sling had broken and the baby had complete ptosis (droopy eye lid) again. The sling was removed and a second frontalis suspension set was placed on the left side using a device from the same lot 021098. After 2 weeks post-operative, the child was doing well. The surgeon reported that she has previously never had a single difficulty with product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1047439-1998-00002 |
| MDR Report Key | 204773 |
| Report Source | 05 |
| Date Received | 1998-12-18 |
| Date of Report | 1998-12-09 |
| Date of Event | 1998-10-29 |
| Date Mfgr Received | 1998-11-23 |
| Device Manufacturer Date | 1998-10-01 |
| Date Added to Maude | 1999-01-07 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5192 FRONTALIS SUSPENSION SET |
| Generic Name | PTOSIS SLING |
| Product Code | HNM |
| Date Received | 1998-12-18 |
| Model Number | 5192 |
| Catalog Number | 5192 |
| Lot Number | 021098 |
| ID Number | * |
| Device Expiration Date | 2003-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 198872 |
| Manufacturer | BECTON DICKINSON |
| 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 | 1998-12-18 |