MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for NEEDLE (PEN NEEDLE DISPOSABLE) manufactured by Unknown.
[184477766]
Patient reports several incidence of his insulin pen needles bending while injecting insulin. No harm to the patient was reported. The patient was educated on proper technique over the phone. This event has been reported by other patient's using this particular brand of needle. Droplet pen needle 8mm ndc 08489-8309-10. Symptoms: 1. Bending insulin needle suspect drug # 1 dosing# use one needle for injection 5 times daily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093844 |
| MDR Report Key | 9853397 |
| Date Received | 2020-03-18 |
| Date of Report | 2019-12-09 |
| Date of Event | 2019-12-09 |
| Date Added to Maude | 2020-03-19 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEEDLE (PEN NEEDLE DISPOSABLE) |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Product Code | FMI |
| Date Received | 2020-03-18 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Product Code | --- |
| Date Received | 2020-03-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |