MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-12 for BD VISITEC 585192 * manufactured by Bd.
[16919706]
The bilateral silicone frontalis slings were placed in eyes due to severe ptosis with a minimal, 2 mm interpalpebral fissure opening, with a maximal brow elevation. Approximately 30 minutes after surgery, the left eye lid was seen to drop into complete ptosis while the patient was crying. The decision was made to bring the patient back into the operating room to revise the frontalis sling of the left eye. This was also done to determine the cause of the failure of the frontalis suspension surgery on the left upper eyelid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1664140 |
| MDR Report Key | 1664140 |
| Date Received | 2010-04-12 |
| Date of Report | 2010-04-12 |
| Date of Event | 2009-11-11 |
| Report Date | 2010-04-12 |
| Date Reported to FDA | 2010-04-12 |
| Date Added to Maude | 2010-04-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BD VISITEC |
| Generic Name | NEEDLE, OPHTHALMIC, OCULOPLASTIC |
| Product Code | HNM |
| Date Received | 2010-04-12 |
| Model Number | 585192 |
| Catalog Number | * |
| Lot Number | 9097077 |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-12 |