MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-08 for SIMPLISSE BY DR BROWN manufactured by Handi-craft Co..
[19726851]
Breast pump causes strangulation on nipple resulting in tearing and bleeding of the skin. Not able to change size of breast shell. Dr. (b)(6). Pt was using the device for 2 weeks. The dr. (b)(6) simplisse double electric pump distributed by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032211 |
| MDR Report Key | 3406795 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-10-07 |
| Date of Event | 2013-10-05 |
| Date Added to Maude | 2013-10-16 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLISSE BY DR BROWN |
| Generic Name | SIMPLISSE |
| Product Code | HGY |
| Date Received | 2013-10-08 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDI-CRAFT CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-08 |