MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-24 for MORCELLATOR manufactured by Unk.
[81010920]
On (b)(6) 2009, reporter stated that she had a laparoscopic robotic myomectomy surgery and a morcellator was used for the procedure which has caused her many problems and abdominal pain. In 2015, she went in for a hysterectomy and the doctor discovered that there were many fibrotic tumors all over her abdomen which are attached to her ovaries, rectus muscles and intestines. The doctor removed most of the tumors but was unable to remove several because this tumors are attached to her blood vessels. On (b)(6) 2017 another surgery was performed for the removal of a tumor that was attached to her belly button. This reporter believed these problems occured as a result of the morcellator device. Reporter said she is suffering and continue to suffer because of the use of the morcellator device that was used during her surgery in 2009, although she is still recovering from the surgery she had on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071190 |
| MDR Report Key | 6739886 |
| Date Received | 2017-07-24 |
| Date of Report | 2017-07-24 |
| Date of Event | 2009-06-05 |
| Date Added to Maude | 2017-07-25 |
| 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 | 0 |
| Brand Name | MORCELLATOR |
| Generic Name | MORCELLATOR |
| Product Code | HET |
| Date Received | 2017-07-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | MORCELLATOR |
| Generic Name | MORCELLATOR |
| Product Code | PTE |
| Date Received | 2017-07-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 | 1. Required No Informationntervention | 2017-07-24 |