MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-29 for LUXFER manufactured by .
[19843806]
On (b)(6) 2011 employee (contracted) was changing e-tank when the tank disengaged releasing o2 while employee was holding onto valve causing burns and frost bite to bilateral hands. Medical products group (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021946 |
| MDR Report Key | 2234278 |
| Date Received | 2011-08-29 |
| Date of Report | 2011-08-18 |
| Date of Event | 2011-08-10 |
| Date Added to Maude | 2011-09-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUXFER |
| Generic Name | E-TANK WITH FLIPSTEM |
| Product Code | ECX |
| Date Received | 2011-08-29 |
| Returned To Mfg | 2011-08-10 |
| Lot Number | 2171102-682 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-29 |