MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-27 for ESSURE ESS305 manufactured by Bayer Pharma Ag.
| Report Number | 2951250-2020-02780 |
| MDR Report Key | 9889791 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-04-03 |
| Date of Event | 2015-08-01 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2014-05-20 |
| Date Added to Maude | 2020-03-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | K SHAW LAMBERSON |
| Manufacturer Street | 100 BAYER BLVD, P.O. BOX 915 |
| Manufacturer City | WHIPPANY NJ 07981 |
| Manufacturer Country | US |
| Manufacturer Postal | 07981 |
| Manufacturer G1 | BAYER PHARMA AG |
| Manufacturer Street | M |
| Manufacturer City | BERLIN, 13353 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 13353 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESSURE |
| Generic Name | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Product Code | HHS |
| Date Received | 2020-03-27 |
| Model Number | ESS305 |
| Lot Number | C59243 |
| Device Expiration Date | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER PHARMA AG |
| Manufacturer Address | M?LLERSTR. 178 BERLIN, 13353 GM 13353 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-27 |