MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-08 for SECHRIST CHAMBERS 3200 manufactured by Sechrist Industries, Inc..
[1712052]
Pt received treatment in a hyperbaric oxygen chamber. He has received 60 similar treatments. When coming out from the chamber, the pt complained of visual loss in both eyes. Pt has received follow up care from an eye specialist. He has been recovering his visual ability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019364 |
| MDR Report Key | 1987884 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-02-08 |
| Date of Event | 2011-01-28 |
| Date Added to Maude | 2011-02-16 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECHRIST CHAMBERS |
| Generic Name | HYPERBARIC OXYGEN CHAMBER |
| Product Code | CBF |
| Date Received | 2011-02-08 |
| Model Number | 3200 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 E LA PALMA AVE ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-08 |