MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-24 for MYOMA SCREW manufactured by Jarit/integra.
[1345335]
During a laparoscopic supra-cervical hysterectomy, the end of myoma screw fractured off and small incision was made to remove it. It was lodged in the subcutaneous tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016494 |
| MDR Report Key | 1738054 |
| Date Received | 2010-06-24 |
| Date of Report | 2010-06-17 |
| Date of Event | 2010-06-14 |
| Date Added to Maude | 2010-06-29 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOMA SCREW |
| Generic Name | NONE |
| Product Code | HHO |
| Date Received | 2010-06-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARIT/INTEGRA |
| Manufacturer Address | MONTGOMERY VILLAGE MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-24 |