MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for DRAINAGE BAG DBAG600 manufactured by Argon Medical Devices, Inc..
[96829668]
Patient Sequence No: 1, Text Type: N, H10
[96829669]
On the argon drainage bag 600ml, both the innate and drain leaked at the seam. Manufacturer response for drainage bag, (brand not provided) (per site reporter). The manufacture will be sending a call tag for the device to do their testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7177941 |
| MDR Report Key | 7177941 |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-12-27 |
| Report Date | 2017-12-28 |
| Date Reported to FDA | 2017-12-28 |
| Date Reported to Mfgr | 2017-12-28 |
| Date Added to Maude | 2018-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAINAGE BAG |
| Generic Name | BAG, BILE COLLECTING |
| Product Code | EXF |
| Date Received | 2018-01-10 |
| Model Number | DBAG600 |
| Catalog Number | DBAG600 |
| Lot Number | 11110997 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | 1445 FLAT CREEK RD. ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |