MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for LASER-LIPO (ADVERTISED AS "FDA APPROVED") manufactured by .
[92877170]
Spa person placed laser devices using cloth straps for a treatment storage bag for urine catheter fully of blood urine. Went to a 7e fit spa for "fda approved laser-lipo with 6 lasers strapped to my abdomen. That night my catheter wire storage bag was full of blood. Photo enclosed. Also spa coupon enclosed. Blood in urine. Procedure performed at 7e fit spa (see attached coupon).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073524 |
| MDR Report Key | 7052430 |
| Date Received | 2017-11-22 |
| Date of Event | 2017-08-02 |
| Date Added to Maude | 2017-11-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LASER-LIPO (ADVERTISED AS "FDA APPROVED") |
| Generic Name | UNK |
| Product Code | OLI |
| Date Received | 2017-11-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-22 |