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 2012-09-12 for SIMPLISSE BY DR. BROWN S1006 manufactured by Handi-craft Co..
[3090239]
Customer called stating that it was painful to use the simplisse double electric pump and she felt electrical shocks during use of the device. She reiterated besides the electrical issue, she was not able to express with the simplisse pump. She followed up with a physician, who was unable to detect any injury from the pump.
Patient Sequence No: 1, Text Type: D, B5
[10237752]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008138005-2012-00003 |
| MDR Report Key | 2799688 |
| Report Source | 04,05,07 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-09-11 |
| Date of Event | 2012-09-04 |
| Date Mfgr Received | 2012-09-10 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-10-31 |
| 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 | SAINT LOUIS MO 63116 |
| Manufacturer Country | US |
| Manufacturer Postal | 63116 |
| Manufacturer Phone | 8779622525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLISSE BY DR. BROWN |
| Generic Name | DOUBLE ELECTRIC BREAST PUMP |
| Product Code | HGY |
| Date Received | 2012-09-12 |
| Returned To Mfg | 2012-09-10 |
| Model Number | S1006 |
| Lot Number | SP 010207 |
| 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 CO. |
| Manufacturer Address | SAINT LOUIS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-09-12 |