MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for FILSHIE CLIPS manufactured by Femcare, Ltd..
[179294190]
I had a tubal ligation (b)(6) 2012. During my c-section, filshie clips were used (2 on each tube). Pain in pelvic area followed, not the same pain as i? Ve experienced with my previous cc-sections. A week post op my throat swelled up and i went to the er, for 7 years i have suffered. To name a few- allergic type symptoms, dizziness, heart palpitations, muscle and joint pains, a rash (biopsy showed something in my body causing this), new allergies to any metals, pelvic pain, inflammation, swelling of the abdomen, migraines, autoimmune type symptoms and about 15 more symptoms. For years i? Ve had labs and all test which come back normal. I was healthy prior to these clips being placed. I was not told filshie clips were used, i only found out 3 months ago after having a x-ray from my chiropractor. The 4 clips are still in my body. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092902 |
| MDR Report Key | 9694024 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-06 |
| Date Added to Maude | 2020-02-11 |
| 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 | FILSHIE CLIPS |
| Generic Name | LAPROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Product Code | KNH |
| Date Received | 2020-02-10 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FEMCARE, LTD. |
| Brand Name | FILSHIE CLIPS |
| Generic Name | LAPROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Product Code | KNH |
| Date Received | 2020-02-10 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | FEMCARE, LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |