MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for TITANFLEX manufactured by Eschenbach Optik Of America, Inc..
[109164983]
On ((b)(6) 2017) last (b)(6), her eyeglasses broke. The consumer went to (b)(6) and purchased new frames. Within a day of wearing the glasses, the consumer stated that she was violently ill. The symptoms included severe headaches, eyes burning, light sensitivity, severe nausea, and heart burn. This only happens when the consumer is wearing the glasses. The consumer stated that two months later she got a second set. Both sets came from (b)(4). The consumer experienced severe fatigue, eye inflammation, and problems seeing at night. The consumer stated that the chemical in the frames is a biocide called methylisothiazolinone. Incident location: home/apartment/condominium - (b)(6), united states. This is my home address. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077407 |
| MDR Report Key | 7536871 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-02 |
| Date of Event | 2017-07-01 |
| Date Added to Maude | 2018-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | TITANFLEX |
| Generic Name | AID, VISION IMAGE INTENSIFICATION |
| Product Code | HOT |
| Date Received | 2018-05-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ESCHENBACH OPTIK OF AMERICA, INC. |
| Brand Name | TITANFLEX |
| Generic Name | AID, VISION IMAGE INTENSIFICATION |
| Product Code | HOT |
| Date Received | 2018-05-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ESCHENBACH OPTIK OF AMERICA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |