MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-27 for MART ANOXOMAT SYSTEM ANX110 NA manufactured by Mart Microbiology Bv.
[2059907]
(b)(6) of (b)(6) hospital center called (b)(4) of (b)(4) to indicate that "a large anoxomat jar exploded, cut employee's face near eye, employee was treated in the emergency room and released. " the employee cannot recall any details of the incident and the hospital will not release the device to the manufacturer, mart microbiology, (b)(4). The manufacturer cannot determine anything further without evaluating the device. (b)(4), a representative from the distributor, (b)(4), visited the hospital, examined the device and spoke to the injured employee. The jar did not explode, however, a 2 inch piece of the lip on the top of the jar was broken off. Pictures and a video are available from (b)(4). (b)(4) did not observe any injuries when she spoke to the injured employee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021048 |
| MDR Report Key | 2136724 |
| Date Received | 2006-03-27 |
| Date of Report | 2006-03-24 |
| Date of Event | 2006-02-27 |
| Date Added to Maude | 2011-06-28 |
| 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 |
| 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 | MART ANOXOMAT SYSTEM |
| Generic Name | ANAEROBIC CHAMBER |
| Product Code | KZJ |
| Date Received | 2006-03-27 |
| Model Number | ANX110 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MART MICROBIOLOGY BV |
| Manufacturer Address | LICHTENVOORDE NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-27 |