FDA Adverse Event
Malfunction
Summary report: N
ZYDERM 1 COLLAGEN IMPALNT (1.0ML)
MDR report key: 1931767
·
Received November 22, 2010
Report
- Report Number
- 2024601-2010-00948
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- October 29, 2010
- Report Date
- November 1, 2010
- Manufacturer
- ALLERGAN
- Product Code
- LMH
- PMA / PMN Number
- P800022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SENT TO FDA ON: (B)(4) 2010.
Description of Event or Problem · 1
DURING PT TREATMENT WITH ZYDERM 1 IN THE "UPPER PERIORAL LIPS", THE NEEDLE DISENGAGED TOTALLY AFTER A NEEDLE CHANGE AND PRODUCT SPILLED. THE NEEDLE FROM THE PACKAGE WAS USED. NO INJURY TO THE PT OR INJECTOR. THE SYRINGE WILL NOT BE RETURNED TO ALLERGAN MEDICAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZYDERM 1 COLLAGEN IMPALNT (1.0ML) | LMH | ALLERGAN | NA | 07K041D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |