MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-07-17 for CHAD THERAPEUTICS OM-411A manufactured by Inovo, Inc.
[6011656]
Drive medical received notice from an attorney of an incident involving an oxygen conserver, a device distributed by a drive company. The device allegedly contained a defective seal and/or contaminates within the product that caused oxygen to leak, resulting in extensive damage to the plaintiff's home. This report is based on information provided by the attorney and healthcare provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2015-00019 |
| MDR Report Key | 4922505 |
| Report Source | * |
| Date Received | 2015-07-17 |
| Date of Report | 2015-06-17 |
| Date of Event | 2013-06-19 |
| Date Facility Aware | 2015-05-19 |
| Report Date | 2015-07-17 |
| Date Reported to FDA | 2015-07-17 |
| Date Reported to Mfgr | 2015-07-17 |
| Date Added to Maude | 2015-07-20 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAD THERAPEUTICS |
| Generic Name | OXYGEN CONSERVER |
| Product Code | NFB |
| Date Received | 2015-07-17 |
| Model Number | OM-411A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INOVO, INC |
| Manufacturer Address | 401 LEONARD BLVD. N LEHIGH ACRES FL 33971 US 33971 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-17 |