MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-24 for RISPERDAL CONSTA manufactured by Ortho-mcniel-janssen.
[15213982]
During patient administration of intramuscular risperdal consta by the pharmacist, the syringe broke apart. This resulted in the medication spilling out of the syringe and on to medical staff and the patient. The needle separated from the syringe and remained in the patient's right arm. The psych-tech removed the needle, and while the pharmacist was cleaning off the patient's arm, the pharmacist got pricked by the needle. Dose or amount: 50 mg (1 syringe); frequency: every 2 weeks; route: intramuscularly in deltoid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022798 |
| MDR Report Key | 2310239 |
| Date Received | 2011-10-24 |
| Date of Report | 2011-10-12 |
| Date of Event | 2011-10-06 |
| Date Added to Maude | 2011-10-27 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RISPERDAL CONSTA |
| Generic Name | RISPERIDONE (PSYCHOTROPIC) INTRAMUSCULAR INJECTION |
| Product Code | KZE |
| Date Received | 2011-10-24 |
| Lot Number | UNKNOWN |
| ID Number | 50458-308-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-MCNIEL-JANSSEN |
| Manufacturer Address | TITUSVILLE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-24 |