MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-11-13 for NUMOBAG NBC 952 manufactured by Numotech, Inc..
[16476005]
Around 2:30 pm, october 2001, a pt receiving topical hyperbaric oxygen therapy at home via the numobag kit, called numotech rep on their cell phone stating that, "i lit a cigarette before my treatment was done and i set the bag on fire and i burned myself. " numotech rep asked if pt had called 911. Pt said they had. Numotech rep stated they were on their way to help. Pt is recovering from third degree burns. No other info available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030595-2001-00001 |
| MDR Report Key | 360339 |
| Report Source | 07 |
| Date Received | 2001-11-13 |
| Date of Report | 2001-11-12 |
| Date of Event | 2000-10-18 |
| Date Mfgr Received | 2001-10-18 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2001-11-20 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR ROBERT FELTON, PRESIDENT, CEO |
| Manufacturer Street | 9420 RESEDA BLVD SUITE 504 |
| Manufacturer City | NORTHRIDGE CA 91324 |
| Manufacturer Country | US |
| Manufacturer Postal | 91324 |
| Manufacturer Phone | 8776866832 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUMOBAG |
| Generic Name | NUMOBAG |
| Product Code | KPJ |
| Date Received | 2001-11-13 |
| Model Number | NUMOBAG |
| Catalog Number | NBC 952 |
| Lot Number | 104109 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 349507 |
| Manufacturer | NUMOTECH, INC. |
| Manufacturer Address | 9420 RESEDA BLVD., SUITE 504 NORTHRIDGE CA 91324 US |
| Baseline Brand Name | NUMOBAG |
| Baseline Generic Name | NUMOBAG |
| Baseline Model No | NUMOBAG |
| Baseline Catalog No | NBC 952 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-11-13 |