MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-13 for POLARIZED SUNGLASSES +89-584-900-2366 CSO 04 7M-125 manufactured by Unk.
[117143805]
On highway (b)(6) at the intersection of (b)(6), i was unable to detect the red light because of my polarized sunglasses. The mfr is (b)(4) made in (b)(4) serial number (b)(4). This intersection was under construction and had installed a new led type of traffic light. The signal appeared to not be working however, as i passed under it, i looked in my rearview mirror and noticed that the signal was red. On my return trip i made sure to check that my glasses blocked the light from the signal. Anyone using these glasses and driving are in grave danger. (b)(4) from (b)(4). Is the product compounded: no; is the product over-the-counter: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079133 |
| MDR Report Key | 7780323 |
| Date Received | 2018-08-13 |
| Date of Report | 2018-08-11 |
| Date of Event | 2018-01-18 |
| Date Added to Maude | 2018-08-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POLARIZED SUNGLASSES |
| Generic Name | POLARIZED SUNGLASSES |
| Product Code | HQY |
| Date Received | 2018-08-13 |
| Model Number | +89-584-900-2366 |
| Catalog Number | CSO 04 7M-125 |
| Lot Number | 62/16 |
| Device Expiration Date | 1999-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Deathisabilit | 2018-08-13 |