MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for ESSURE PERMANENT BIRTH CONTROL ESS305 manufactured by Bayer.
[90974684]
Introducer for bayer essure permanent birth control was bent upon opening, thereby not allowing the device to pass. Replaced with one of the same lot number with no further issues noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073100 |
| MDR Report Key | 6996123 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-27 |
| Date Added to Maude | 2017-11-02 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ESSURE PERMANENT BIRTH CONTROL |
| Generic Name | ESSURE |
| Product Code | HHD |
| Date Received | 2017-11-02 |
| Model Number | ESS305 |
| Catalog Number | ESS305 |
| Lot Number | HE012XW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER |
| Manufacturer Address | WHIPPANY NJ 07981 US 07981 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-02 |