MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-13 for TUBAL LIGATION - PARKLAND METHOD manufactured by Unk.
[180042219]
Since my tubal ligation i have experienced near constant nausea and dizziness, pelvic pain, intense pain with ovulation, headaches that last for days with minimal relief from otc pain relievers. My muscles ache all the time and tense up about a week before my period. My pms is like early pregnancy symptoms (fatigue, nausea, dizziness, etc) i have near constant breast pain. My pms symptoms often last 3 weeks - 1 month. My period flow is heavier and consist of clots. (sometimes the size of my palm) i never experienced any of the above symptoms in correlation to my monthly cycles before the birth of my 3rd child/ tubal ligation. I have had my hormones checked. My thyroid checked 3xs in the span of 1 1/2 years and had cbc and cmet drawn all in normal limits. Also had a ct scan of my head which was normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093014 |
| MDR Report Key | 9711779 |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-11 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | TUBAL LIGATION - PARKLAND METHOD |
| Generic Name | LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Product Code | KNH |
| Date Received | 2020-02-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |