MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-14 for SECHRIST 4100HR 4100H manufactured by Sechrist Industries.
[33476535]
Patient underwent hyperbaric oxygen treatment. After treatment completed and she was brought out of the chamber, the patient complained her arms were hurting. Radiology exams were completed and found that there were bilateral dislocations and fractures of the shoulders.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5292726 |
| MDR Report Key | 5292726 |
| Date Received | 2015-12-14 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-11-04 |
| Date Facility Aware | 2015-11-04 |
| Report Date | 2015-12-09 |
| Date Reported to FDA | 2015-12-09 |
| Date Reported to Mfgr | 2015-12-01 |
| Date Added to Maude | 2015-12-14 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SECHRIST |
| Generic Name | HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2015-12-14 |
| Model Number | 4100HR |
| Catalog Number | 4100H |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES |
| Manufacturer Address | 4225 E. LAPALMA AVE. ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-12-14 |