MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-19 for LAMINARIA manufactured by .
[21609273]
Reporter states that the laminaria was implanted in 2008 and was explanted on the next day. Stated that pt woke up and was unable to move. Went to hosp to have device removed. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005438 |
| MDR Report Key | 999181 |
| Date Received | 2008-02-19 |
| Date of Report | 2008-02-19 |
| Date of Event | 2008-02-19 |
| Date Added to Maude | 2008-02-22 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | LAMINARIA |
| Generic Name | NONE |
| Product Code | HDY |
| Date Received | 2008-02-19 |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 969268 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-19 |