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 2011-11-21 for SIMPLISSE S1006 manufactured by Simplisse Inc.
[15578020]
On (b)(6), case (b)(6) felt a lump in her breast. She contacted her midwife who diagnosed mastitis. The midwife prescribed antibiotics on (b)(6) 2011. On (b)(6), case (b)(6) attempted to use the breast pump and was not able to express milk.
Patient Sequence No: 1, Text Type: D, B5
[15869776]
On (b)(6) 2011 case (b)(6) contacted (b)(4) via e-mail to report that she did not have a successful pumping session. (b)(4) sent replacement parts. On (b)(6) 2011, (b)(4) spoke with case (b)(6). She stated that she was having difficulty letting down. Case (b)(6) stated that she is very stressed and thinks that is why but would like to speak with our lactation consultant for advice. Case (b)(6) reported that she is fighting with husband. On (b)(4) 2011, case (b)(6) contacted (b)(4) via email to report that the lactation consultant's advice has helped a little and that the help was appreciated. On (b)(6) 2011, (b)(4) left a voice message to f/u. On (b)(6) 2011 (b)(4) left a message. On (b)(6) 2011, case (b)(6) returned the call with an update. The parts are working correctly. Case (b)(6) is expressing 5 oz in 20 minutes currently. Baby is (b)(6) old. Case (b)(6) reports that the stress level at home is what is hindering her milk flow. Lactation consultant has advised case (b)(6) in stress-reducing techniques.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008138005-2011-00005 |
| MDR Report Key | 2375584 |
| Report Source | 04,05,07 |
| Date Received | 2011-11-21 |
| Date of Report | 2011-11-18 |
| Date of Event | 2011-11-01 |
| Date Mfgr Received | 2011-11-18 |
| Date Added to Maude | 2012-07-17 |
| 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 |
| 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 ELECTRIC BREAST PUMP |
| Product Code | HGY |
| Date Received | 2011-11-21 |
| Model Number | S1006 |
| 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 | 2011-11-21 |