MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-15 for BED BUDDY BBF2000-12 manufactured by Compass Health Brands.
[111194669]
Inspection observations: upon inspection, the item was found to be used with normal wear. The customer stated that right after she applied to the skin the fabric ripped opened and the fabric beads started touching the skin. The unit was found to have a one inch burn/rip in the center region of the wrap, on a seam. The bottom right corner was also found to have some discoloration. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111194670]
The end-user heated the device in the microwave for 3 minutes. She then applied it directly to her bare neck and she burnt her neck, collarbone and shoulder. It burnt through the skin and she had open sores. The next day it turned red. Right after she applied it to her skin the fabric ripped opened and the fabric beads started touching her skin and opened up the skin. She immediately took it off. When she put it in the microwave she hit the number 3 and she left it in the microwave until it stopped. She assumes that the bed buddy was at room temperature prior to heating. The instructions state the following: microwave bed buddy for 1 minute and 15 seconds at standard power. Do not leave bed buddy unattended while heating. Microwave heating times vary - do not overheat. Always touch-test by shifting contents to check for hot spots before use. If higher heat is required, continue microwaving in 15 second intervals. Do not exceed 2 minutes total heating time. The end-user did not follow the heating instructions and overheated the device by a minimum of 1 minute and a maximum of 1 minute 45 seconds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00032 |
| MDR Report Key | 7605470 |
| Report Source | CONSUMER |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-22 |
| Date Facility Aware | 2018-05-25 |
| Report Date | 2018-06-15 |
| Date Reported to FDA | 2018-06-15 |
| Date Reported to Mfgr | 2018-06-15 |
| Date Mfgr Received | 2018-05-25 |
| Date Added to Maude | 2018-06-15 |
| 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 | BODY WRAP |
| Product Code | IMA |
| Date Received | 2018-06-15 |
| Model Number | BBF2000-12 |
| Catalog Number | BBF2000-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-15 |