MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 1997-10-07 for RAY-BAN S5 W2231 manufactured by Bausch & Lomb, Inc..
[102504]
Consumer alleges an injury requiring medical treatment, caused by his sunglasses when he was involved in an automobile accident. Consumer has refused to continue contact or provide medical detail since receiving his sunglasses back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643383-1997-00009 |
| MDR Report Key | 125726 |
| Report Source | 04,05 |
| Date Received | 1997-10-07 |
| Date of Report | 1997-09-10 |
| Date of Event | 1997-01-12 |
| Date Mfgr Received | 1997-04-14 |
| Date Added to Maude | 1997-10-15 |
| 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 | 1997-10-07 |
| Returned To Mfg | 1997-04-14 |
| Model Number | S5 |
| Catalog Number | W2231 |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 123073 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | 5335 CASTROVILLE RD. SAN ANTONIO TX 78227 US |
| Baseline Brand Name | RAY-BAN SUNGLASSES |
| Baseline Generic Name | SUNGLASSES |
| Baseline Model No | S5 |
| Baseline Catalog No | W2231 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-07 |