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.
[186331764]
This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('had a hysterectomy') in a female patient who had essure inserted. On an unknown date, the patient had essure inserted. On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required). The patient was treated with surgery (hysterectomy). Essure was removed. At the time of the report, the medical device removal outcome was unknown. The reporter considered medical device removal to be related to essure. Concerning the injuries reported in this case, the following one was reported via social media: medical device removal. Quality-safety evaluation of ptc: unable to confirm complaint. Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951250-2020-02768 |
| MDR Report Key | 9888630 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-04-03 |
| Date Mfgr Received | 2020-03-06 |
| 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 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 |