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 2012-01-06 for SIMPLISSE S1005 manufactured by Simplisse Inc.
[2516642]
On (b)(6) 2011, case (b)(4) reported that she had been diagnosed by her physician with mastitis the last week in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008138005-2012-00001 |
| MDR Report Key | 2426599 |
| Report Source | 04,05,07 |
| Date Received | 2012-01-06 |
| Date of Report | 2012-01-03 |
| Date of Event | 2011-11-28 |
| Date Mfgr Received | 2011-12-29 |
| Date Added to Maude | 2012-07-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4433 FYLER AVE. |
| Manufacturer City | SAINT LOUIS MO 63116 |
| Manufacturer Country | US |
| Manufacturer Postal | 63116 |
| Manufacturer Phone | 3147739273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLISSE |
| Generic Name | DOUBLE ELETRIC BREAST PUMP |
| Product Code | HGY |
| Date Received | 2012-01-06 |
| Returned To Mfg | 2011-12-29 |
| Model Number | S1005 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIMPLISSE INC |
| Manufacturer Address | SAINT LOUIS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-06 |