MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-10 for REBIJECT II UNK manufactured by Emd Serono.
[2766662]
This device requires proper training. I did not receive adequate training by mfr. I tried to use this device on (b)(6) 2012 and it didn't work; when i removed pieces and tried to reinstall syringe, drug came out of vial. I tried again on (b)(6) 2012 and device worked but caused bad bleeding on injection site. Told emd serono about problem, but i was never contacted about returning product. Called ms lifelines, told them about multiple problems-but they do not believe me. I have multiple sclerosis. This device is used for injecting a drug.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025907 |
| MDR Report Key | 2627223 |
| Date Received | 2012-06-10 |
| Date of Report | 2012-06-14 |
| Date of Event | 2012-06-01 |
| Date Added to Maude | 2012-06-26 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REBIJECT II |
| Generic Name | AUTO INJECT DEVICE FOR INJECTING SHOTS |
| Product Code | KZE |
| Date Received | 2012-06-10 |
| Model Number | REBIJECT II |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMD SERONO |
| Manufacturer Address | ONE TECHNOLOGY PLACE ROCKLAND MA 02370 US 02370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-10 |