MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-01-22 for FOAM/GEL PAD 9153647208 IVCGFMO2 manufactured by Unknown.
[5316240]
The dealer stated, the brand new unit was leaking out of the box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2015-00471 |
| MDR Report Key | 4439970 |
| Report Source | * |
| Date Received | 2015-01-22 |
| Date of Report | 2015-01-14 |
| Date Facility Aware | 2015-01-14 |
| Report Date | 2015-01-21 |
| Date Reported to FDA | 2015-01-21 |
| Date Reported to Mfgr | 2015-01-21 |
| Date Added to Maude | 2015-01-22 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOAM/GEL PAD 9153647208 |
| Generic Name | CUSHION, WHEELCHAIR |
| Product Code | IMP |
| Date Received | 2015-01-22 |
| Model Number | IVCGFMO2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-22 |