FDA Adverse Event
Injury
Summary report: N
HYLAN G-F 20
MDR report key: 2244022
·
Received September 6, 2011
Report
- Report Number
- MW5022174
- Event Type
- Injury
- Date Received
- September 6, 2011
- Date of Event
- August 3, 2011
- Report Date
- September 6, 2011
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT HAD INJECTION ON (B)(6) 2011. PATIENT REPORTS ADR ON (B)(6) 2011. PATIENT TAKING OTC BENADRYL WITHOUT RELIEF. PATIENT SEEN IN EMERGENCY ROOM ON (B)(6) 2011. SYMPTOMS: RASH, URTICARIA PRURITUS. DOXEPIN DOSE: 10, UNITS: MG, FREQ: PRN, ROUTE: PO, DOSE: 48 MG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYLAN G-F 20 | INJECTION | MOZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |