MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-08-02 for FLYNN SCLERAL DEPRESSOR E5107 manufactured by Bausch & Lomb Surgical.
[149844]
During surgery, the instrument had a rough edge and cut the pt's eye. Ointment was applied to the eye. There has been no report of add'l injury as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-2000-00005 |
| MDR Report Key | 288231 |
| Report Source | 06 |
| Date Received | 2000-08-02 |
| Date of Report | 2000-07-28 |
| Date of Event | 2000-07-17 |
| Date Mfgr Received | 2000-07-28 |
| Date Added to Maude | 2000-08-07 |
| 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 |
| Manufacturer Contact | ROBIN EMS |
| Manufacturer Street | 3365 TREE COURT INDUST. BLVD |
| Manufacturer City | ST LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263276 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLYNN SCLERAL DEPRESSOR |
| Generic Name | OPHTHALMIC DEPRESSOR |
| Product Code | HNX |
| Date Received | 2000-08-02 |
| Model Number | NA |
| Catalog Number | E5107 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 278930 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 499 SOVEREIGN CT. MANCHESTER MO 63011 US |
| Baseline Brand Name | DEPRESSOR SCLERAL FLYNN |
| Baseline Generic Name | OPHTHALMIC DEPRESSOR |
| Baseline Model No | NA |
| Baseline Catalog No | E5107 |
| Baseline ID | NA |
| Baseline Device Family | OPHTHALMIC DEPRESSOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-08-02 |