MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-15 for THERABEAD SINUS PAIN RELIEF MOIST HEAT COMPRES 616-4509-0000 manufactured by Briggs Medical Service Company.
[2263181]
End user stated she was burned on her knee by therabeads. Her knee was bothering her, so she asked her nephew to heat up the therabeads for her. He wiped it with a damp rag and patted it dry before microwaving it for 1 minute and 40 seconds. She laid it on her bed, waited 30 minutes, then laid on top of the pad on the bed on her right side. Later on, she felt the pad steaming, so she threw it on the floor. She didn't put the lights on, but went to the shower, where she discovered a scab fall off, approximately 3" beside her scar, with a burn area measuring approximately 3" x 6". She went to her surgeon, who x-rayed her knee and prescribed cipro for her. She then went to her pcp doctor, who changed her to silvadene and cipro and sent her to wound care because she had a "very bad burn. " wound care who put acusil on the burn, with a band-aid over and then waterproof coating.
Patient Sequence No: 1, Text Type: D, B5
[9403732]
The patient misunderstood the instructions for use. She thought that the compress needed to be moistened prior to heating. The instructions state to place the pad in a clean microwave and heat at full power for 60 seconds. Users are instructed to touch test the pad before using. If the user desires more heat, they can continue to heat in 30 seconds intervals until the desired temperature is reached. They are instructed to always touch test the pad after each additional 30 second interval. There is a note for the end user to lightly touch test the product to determine uniform, safe heat levels prior to applying to treatment area. For the maintenance of the pad, users are to only surface wipe (clean water only) the pad with a damp cloth if it becomes soiled and allow the pad to air dry thoroughly before storage or use. This product is no longer manufactured at the (b)(4) facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219232-2011-00008 |
| MDR Report Key | 2218507 |
| Report Source | 04 |
| Date Received | 2011-08-15 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-07-16 |
| Date Facility Aware | 2011-07-26 |
| Report Date | 2011-08-12 |
| Date Reported to FDA | 2011-08-12 |
| Date Mfgr Received | 2011-07-26 |
| Date Added to Maude | 2011-08-24 |
| 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 | JERI HILL, MANAGER |
| Manufacturer Street | 1931 NORMAN DRIVE, S. |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475735947 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABEAD SINUS PAIN RELIEF MOIST HEAT COMPRES |
| Generic Name | THERABEADS |
| Product Code | IMA |
| Date Received | 2011-08-15 |
| Model Number | 616-4509-0000 |
| Catalog Number | 616-4509-0000 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRIGGS MEDICAL SERVICE COMPANY |
| Manufacturer Address | 1788 W. CHERRY ST. JESUP GA 31545 US 31545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-15 |