MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-08 for INFU-SURG 950194210 manufactured by Ethox Llc..
[99824478]
The customer alleges that there is a "the infuser bag did not maintain pressure" no other details were provided and no patient injury/harm reported. The customer did not return any product to be evaluated and no lot number was provided. The investigator could not confirm or dispute claim without inspecting actual affected product; but investigator can confirm problem through trending of previous complaints.
Patient Sequence No: 1, Text Type: N, H10
[99824479]
The customer alleges that "the infuser bag did not maintain pressure. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2018-00001 |
| MDR Report Key | 7251254 |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-08 |
| Date of Event | 2018-01-12 |
| Date Added to Maude | 2018-02-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | ETHOX LLC. |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INFU-SURG |
| Generic Name | PRESSURE INFUSER BAG |
| Product Code | KZD |
| Date Received | 2018-02-08 |
| Model Number | 950194210 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHOX LLC. |
| Manufacturer Address | 2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-08 |