MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 1997-08-11 for RAY-BAN UNK manufactured by Bausch & Lomb, Inc..
[14870524]
Consumer alleges an injury requiring medical treatment, caused by his sunglasses when he walked into a chain link fence while playing tennis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643383-1997-00005 |
| MDR Report Key | 113462 |
| Report Source | 04,05 |
| Date Received | 1997-08-11 |
| Date of Report | 1997-06-23 |
| Date of Event | 1996-12-08 |
| Date Mfgr Received | 1997-06-18 |
| Date Added to Maude | 1997-08-19 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAY-BAN |
| Generic Name | SUNGLASS |
| Product Code | HQY |
| Date Received | 1997-08-11 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 111384 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | 5335 CASTROVILLE RD. SAN ANTONIO TX 78227 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-08-11 |