MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for CALVIN KLEIN BLACK LADIES' SUNGLASSES R696S 001 58 16140 #3 manufactured by Unknown.
[141574335]
Sunglasses noted to emit a very strong chemical smell after purchase. The smell is so powerful that i am unable to wear them. This is the second pair of sunglasses that i have purchased that has this pungent chemical smell. The chemicals used are irritating when breathed in. Estimate date of purchase (b)(6) 2018. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085706 |
| MDR Report Key | 8497226 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-01 |
| Date Added to Maude | 2019-04-09 |
| 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 | CALVIN KLEIN BLACK LADIES' SUNGLASSES |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 2019-04-08 |
| Model Number | R696S 001 58 16140 #3 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |