MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,07 report with the FDA on 2013-10-03 for SIMPLISSE BY DR. BROWN S1006 manufactured by Handi-craft Company.
[22141570]
On (b)(6) 2013 case (b)(4) reported that she had been diagnosed by a physician with mastitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008138005-2013-00006 |
| MDR Report Key | 3409247 |
| Report Source | 04,05,07 |
| Date Received | 2013-10-03 |
| Date of Report | 2013-10-03 |
| Date of Event | 2013-09-03 |
| Date Mfgr Received | 2013-09-03 |
| Date Added to Maude | 2013-11-12 |
| 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 Street | 4433 FYLER AVE |
| Manufacturer City | SAIT LOUIS MO 63116 |
| Manufacturer Country | US |
| Manufacturer Postal | 63116 |
| Manufacturer Phone | 3147732979 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLISSE BY DR. BROWN |
| Generic Name | NONE |
| Product Code | HGY |
| Date Received | 2013-10-03 |
| Returned To Mfg | 2013-09-27 |
| Model Number | S1006 |
| Lot Number | SPO 10207 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDI-CRAFT COMPANY |
| Manufacturer Address | ST. LOUIS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-03 |