FDA Adverse Event
Injury
Summary report: N
LIFESTYLES WARM LOVIN'
MDR report key: 4309889
·
Received October 14, 2014
Report
- Report Number
- 1019632-2014-00015
- Event Type
- Injury
- Date Received
- October 14, 2014
- Report Date
- October 14, 2014
- Manufacturer
- IDS MFG LIMITED
- Product Code
- NUC
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). - ANSELL HEALTHCARE PRODUCTS LLC IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4).
Description of Event or Problem · 1
THE CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS, LLC THAT AFTER USING A LIFESTYLES PERSONAL LUBRICANT HE EXPERIENCED A SEVERE ALLERGIC REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651457 | LIFESTYLES WARM LOVIN' | PERSONAL LUBRICANT | NUC | IDS MFG LIMITED | 11120605DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |