FDA Adverse Event
Malfunction
Summary report: N
ADAPTOR, HOLDER, SYRINGE
MDR report key: 7999925
·
Received October 23, 2018
Report
- Report Number
- MW5080791
- Event Type
- Malfunction
- Date Received
- October 23, 2018
- Date of Event
- October 17, 2018
- Report Date
- October 18, 2018
- Manufacturer
- ABBVIE MEDICAL DEVICE CENTER
- Product Code
- IQG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT SAYS THAT GRAY NEEDLE COVER DOES NOT LOOK RIGHT ON HIS CURRENT PEN. "EVENT RESOLVED, PROVIDED MFR'S PHONE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 836187 | ADAPTOR, HOLDER, SYRINGE | ADAPTOR, HOLDER, SYRINGE | IQG | ABBVIE MEDICAL DEVICE CENTER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |