MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-10 for VIP VIP-CBS-11 NONE manufactured by Vanarsdale Innovative Products Inc..
[1372983]
Patient got a burn below left breast from custom breast support remaining too hot. It is believed that the sponge frame contained too much hot water. ====================== health professional's impression======================hot water is necessary to form the breast support. The hot water may not have been entirely squeezed out of sponge frame.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1842771 |
| MDR Report Key | 1842771 |
| Date Received | 2010-09-10 |
| Date of Report | 2010-05-27 |
| Date of Event | 2010-05-04 |
| Report Date | 2010-05-27 |
| Date Reported to FDA | 2010-09-10 |
| Date Added to Maude | 2010-09-23 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIP |
| Generic Name | CUSTOM BREAST SUPPORT |
| Product Code | HEF |
| Date Received | 2010-09-10 |
| Model Number | VIP-CBS-11 |
| Catalog Number | NONE |
| Lot Number | NONE |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VANARSDALE INNOVATIVE PRODUCTS INC. |
| Manufacturer Address | 4660 VOYAGER DR PENSACOLA FL 32514 US 32514 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-10 |