MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-20 for LAMINARIA TENT manufactured by .
[802881]
Patient admitted to hosp. In paralysis suspected to be caused by a laminaria tent. Diagnosis or reason for use: abortion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005618 |
| MDR Report Key | 1002025 |
| Date Received | 2008-02-20 |
| Date of Report | 2008-02-20 |
| Date of Event | 2008-02-18 |
| Date Added to Maude | 2008-02-28 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | LAMINARIA TENT |
| Product Code | HDY |
| Date Received | 2008-02-20 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 971437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2008-02-20 |