MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-07 for PERIDOX RTU manufactured by Contec.
[57114945]
On (b)(6) 2016 - pharmacy technician used peridox rtu to disinfect cleanroom facility and experienced burning and itching to eyes. He was assigned to clean on (b)(6) 2016 and experienced burning and itching to eyes that became red and required md visit and treatment. On (b)(6) 2016 - another pharmacy technician experienced burning feeling and redness to eyes. On (b)(6) 2016 - one pharmacy technician states that she gets cough and lingering respiratory issues for a few hours after cleaning with peridox, wearing n95 mask. On (b)(6) 2016 - one pharmacy technician states she gets burning sensation in her nasal passages and throat during the use of peridox. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2016. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065265 |
| MDR Report Key | 6016831 |
| Date Received | 2016-10-07 |
| Date of Report | 2016-10-06 |
| Date of Event | 2016-07-12 |
| Date Added to Maude | 2016-10-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| 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 | PERIDOX RTU |
| Generic Name | DISINFECT |
| Product Code | LRJ |
| Date Received | 2016-10-07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-07 |