MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-30 for LAMINARIA EXTRA SMALL INTRAVAGINAL R58-200S, R58-200 manufactured by Rocket Usa.
[14539]
Package double-label-small matches actual size of device found inside. 2nd or outer label says extra small. Lot # same on both labels & devices. Outer label 200s. Inner label 200.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007475 |
| MDR Report Key | 27528 |
| Date Received | 1995-10-30 |
| Date of Report | 1995-10-26 |
| Date of Event | 1995-10-01 |
| Date Added to Maude | 1995-10-30 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAMINARIA EXTRA SMALL INTRAVAGINAL |
| Generic Name | CERVICAL DILATOR |
| Product Code | HDY |
| Date Received | 1995-10-30 |
| Model Number | R58-200S, R58-200 |
| Lot Number | 0801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 28440 |
| Manufacturer | ROCKET USA |
| Manufacturer Address | ALPHARETTA GA 30201 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-10-30 |