MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for HULKA CLIP manufactured by Richard Wolf Medical Instruments Corp..
[179108877]
On (b)(6) 2001 i had my tubes tied. For many years i suffered different symptoms and problems. After researching i had my tubes removed 12? Years later. The symptoms i was having and issues were a reaction to the hulka clip that was used. I knew my body even if doctors disagreed. It took me years to find one that listened. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092897 |
| MDR Report Key | 9693873 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-06 |
| Date of Event | 2001-10-31 |
| 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 | HULKA CLIP |
| Generic Name | LAPROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Product Code | KNH |
| Date Received | 2020-02-10 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-02-10 |