MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-06-21 for BED BUDDY BBF2200-12 manufactured by Compass Health Brands.
[112502119]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[112502120]
Customer has had for 2 weeks and used everyday with no problems. End user placed in microwave for 1 minute, laid flat in microwave and went to brush his teeth in bathroom. Microwave is in the bedroom and when wife looked over she saw the microwave was on fire. He then took microwave and threw in the bath tub. The instructions state the following: microwave bed buddy for 30 seconds at standard power. Do not leave bed buddy unattended while heating. Microwave heating times vary - do not overheat. If higher heat is required, continue microwaving in 15 second intervals. Do not exceed 1 minute total heating time. The end-user did not follow the heating instructions and overheated the device by 30 seconds and he walked away and left the device alone while heating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00034 |
| MDR Report Key | 7626485 |
| Report Source | OTHER |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-21 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-06-21 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CYNTHIA TONEY |
| Manufacturer Street | 6753 ENGLE ROAD |
| Manufacturer City | MIDDLEBURG HEIGHTS 44130 |
| Manufacturer Country | US |
| Manufacturer Postal | 44130 |
| Manufacturer Phone | 4402682110 |
| Manufacturer G1 | COMPASS HEALTH BRANDS |
| Manufacturer Street | 6753 ENGLE ROAD |
| Manufacturer City | MIDDLEBURG HEIGHTS 44130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BED BUDDY |
| Generic Name | JOINT WRAP |
| Product Code | IME |
| Date Received | 2018-06-21 |
| Model Number | BBF2200-12 |
| Catalog Number | BBF2200-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMPASS HEALTH BRANDS |
| Manufacturer Address | 6753 ENGLE ROAD MIDDLEBURG HEIGHTS 44130 US 44130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-21 |