MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-01-17 for BIOSONIC RM 510 BS NA manufactured by Rich-mar Corp..
[812697]
Pt was undergoing a plastic surgery procedure which included therapeutic ultrasound to each jowl. From this treatment, the pt is claiming "severe and permanent injury", which causes her to endure "great pain", suffering and scaring".
Patient Sequence No: 1, Text Type: D, B5
[7930587]
Artison was notified of this incident when we were named in a lawsuit. This product was notified back in october of 2007. They called rich-mar naimco (they had purchased the rich-mar name along with the physical therapy line of products from us in may of 2007). We do not actually know the severity of the alleged burn, and believe that the device was functioning as it should. The operators manual cautions against using the device over anestheized areas.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1623423-2008-00001 |
| MDR Report Key | 983662 |
| Report Source | 08 |
| Date Received | 2008-01-17 |
| Date of Report | 2008-01-10 |
| Date of Event | 2004-01-06 |
| Date Mfgr Received | 2008-01-10 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2008-01-29 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID RICHARDS |
| Manufacturer Street | 15499 EAST 590TH RD. P.O. BOX 879 |
| Manufacturer City | INOLA OK 74036 |
| Manufacturer Country | US |
| Manufacturer Postal | 74036 |
| Manufacturer Phone | 918543222 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSONIC |
| Generic Name | THERAPEUTIC ULTRASOUND |
| Product Code | IMI |
| Date Received | 2008-01-17 |
| Model Number | RM 510 BS |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 953572 |
| Manufacturer | RICH-MAR CORP. |
| Manufacturer Address | INOLA OK US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-17 |