MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for PERFECTO2 V WITH SENSOR 9153650799 NA:IRC5PO2V IRC5PO2V manufactured by Invacare Florida.
[174902039]
Based on the limited information provided, we are investigation this complaint further. There is no allegation that the invacare device malfunctioned. When additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[174902040]
Customer states she received an irc5po2v concentrator from apria. She stated when the unit arrived, it was only in her house for 5 - 10 minutes when she had a severe allergic reaction. She states in this instance, the reaction she had was systemic, her nose was burning, she had gi swelling and distress, throat swelling, vomiting, and small hives all over her body. She states she administered an epi pen to herself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2020-00001 |
| MDR Report Key | 9546008 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-06 |
| Date Mfgr Received | 2020-01-03 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE FLORIDA |
| Manufacturer Street | 2101 EAST LAKE MARY BLVD |
| Manufacturer City | SANFORD FL 32773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFECTO2 V WITH SENSOR 9153650799 |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-01-03 |
| Model Number | NA:IRC5PO2V |
| Catalog Number | IRC5PO2V |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE FLORIDA |
| Manufacturer Address | 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-01-03 |