MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-02-06 for RS-LFS LUMBAR FUNCTIONAL SYSTEM manufactured by Rs Medical.
[1039373]
Patient reported to sales representative that the rs-lfs lumbosacral brace is rupturing her breast implant. Patient went to her doctor. Medical records were reviewed from attending physician. The same day visit, mentions that the rs medical account manager had fitted the patient with rs-lfs and according to patient, it later caused the right breast implant to rupture. Doctor explained to patient that lumbosacral braces are not contraindicated in persons with breast implants. Physician's notes state "(patient) states that back brace made breast implant bursts but (rs medical account manager) was not informed that she had implants. Dr (plastic surgeon) stated that brace could have caused rupture".
Patient Sequence No: 1, Text Type: D, B5
[8155442]
Device related causality of the reported event was not determinable. Product was visually and dimensionally inspected and met specifications with no apparent damage noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644243-2009-00001 |
| MDR Report Key | 1311264 |
| Report Source | 04 |
| Date Received | 2009-02-06 |
| Date of Report | 2009-01-05 |
| Date Mfgr Received | 2009-01-05 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2009-02-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIMOTHY JOHNSON, DIRECTOR |
| Manufacturer Street | 14001 S.E. FIRST STREET |
| Manufacturer City | VANCOUVER WA 986843509 |
| Manufacturer Country | US |
| Manufacturer Postal | 986843509 |
| Manufacturer Phone | 3608234940 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RS-LFS LUMBAR FUNCTIONAL SYSTEM |
| Generic Name | LUMBOSACRAL BRACE - SPINAL ORTHOSIS |
| Product Code | IPY |
| Date Received | 2009-02-06 |
| Model Number | RS-LFS |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RS MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-06 |