FDA Adverse Event
Other
Summary report: N
LIFESTYLES ULTRA SENSITIVE
MDR report key: 2226729
·
Received August 22, 2011
Report
- Report Number
- 1019632-2011-00007
- Event Type
- Other
- Date Received
- August 22, 2011
- Report Date
- August 18, 2011
- Manufacturer
- SURETEX PROPHYLACTICS (INDIA) LTD.
- Product Code
- HIS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - ANSELL HEALTHCARE PRODUCTS IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4).
Description of Event or Problem · 1
THIS CUSTOMER SENT A COMPLAINT TO OUR COMPANY INFORMING THAT HE HAS SOUGHT MEDICAL ATTENTION AFTER USING ONE OF OUR PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTYLES ULTRA SENSITIVE | LUBRICATED LATEX CONDOMS | HIS | SURETEX PROPHYLACTICS (INDIA) LTD. | 1011051622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |