FDA Adverse Event
Death
Summary report: N
TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC
MDR report key: 2153031
·
Received June 23, 2011
Report
- Report Number
- 1219109-2011-00007
- Event Type
- Death
- Date Received
- June 23, 2011
- Report Date
- June 2, 2011
- Manufacturer
- TAMBRANDS MANUFACTURING, INC.
- Product Code
- HIL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
LOT NUMBER WAS NOT PROVIDED BY CONSUMER AND PRODUCT NOT REC'D TO DATE, THEREFORE, UNABLE TO PROCEED WITH THE PRODUCT INVESTIGATION. PROCTER & GAMBLE (P&G) IS SUBMITTING THIS REPORT ONLY BECAUSE IT BELIEVES AN EVENT THAT MEETS THE REQUIREMENTS OF 21 CFR PART 803 MAY HAVE OCCURRED.
Description of Event or Problem · 1
POISONED BY PRODUCT (TAMPAX) [DEVICE TOXICITY]. CASE DESCRIPTION: A CONSUMER REPORTED VIA EMAIL THAT HE WAS TOLD BY A CORONER, HIS WIFE HAS BEEN POISONED BY TAMPAX TAMPONS. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC | NONE | HIL | TAMBRANDS MANUFACTURING, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |