MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for HYPERBARIC OXYGENATION manufactured by Hiperbaricas Del Ecuador.
[115780251]
I went to the (b)(6) in (b)(6) after one week of hysterectomy. When i left there i felt bad my "presion" was down and when i arrived to my house i had fever. I called to the center and the receptionist told me that the dr called me. He did not call me and i suspected the other session. My gastroenterologist sent me a test and the results after 2 days is that i have (b)(6) and i have to follow a treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078725 |
| MDR Report Key | 7738937 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-29 |
| Date of Event | 2018-07-27 |
| Date Added to Maude | 2018-08-01 |
| 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 | HYPERBARIC OXYGENATION |
| Generic Name | CHAMBER HYPERBARIC |
| Product Code | CBF |
| Date Received | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HIPERBARICAS DEL ECUADOR |
| Manufacturer Address | KM 2.5 VIA SAMBORONDON EDIF DIANA QUINTANA LOCAL 3, EC092301 GUAYAQUIL 092301 EC 092301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |