FDA Adverse Event
Other
Summary report: N
KOTEX SECURITY TAMPON REGULAR
MDR report key: 740035
·
Received June 25, 2006
Report
- Report Number
- 2381757-2006-00002
- Event Type
- Other
- Date Received
- June 25, 2006
- Date of Event
- June 22, 2006
- Report Date
- June 25, 2006
- Manufacturer
- KIMBERLY-CLARK CORP.
- Product Code
- HEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RECALL # 2183996-03/21/06-001-R.
Description of Event or Problem · 1
KIMBERLY-CLARK CORP. RECEIVED NOTICE ON 6/26/2006 FROM A TAMPON USER THAT AT THE END OF HER LAST CYCLE, THAT ENDED IN 2006, SHE THOUGHT THAT SHE HAD REMOVED HER LAST TAMPON BECAUSE SHE DID NOT DETECT A STRING. AT THE TIME OF HER SUBSEQUENT CYCLE SHE CLAIMED THAT SHE WAS EXPERIENCING CERVICAL PAIN, AND A FOUL SMELLING DISCHARGE. DURING A PELVIC EXAMINATION THE SUBJECT SAID THAT HER DOCTOR DISCOVERED THAT SHE, IN FACT, HAD NOT REMOVED THE LAST TAMPON FROM HER PREVIOUS PERIOD. THE TAMPON WAS REMOVED, AND THE SUBJECT WAS GIVEN A SHOT FOR TETANUS, AND MEDICATION FOR TREATING VAGINAL INFECTIONS. THE REMOVED TAMPON HAD THE REMOVAL STRING STILL ATTACHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KOTEX SECURITY TAMPON REGULAR | UNSCENTED MENSTRUAL TAMPON | HEB | KIMBERLY-CLARK CORP. | NA | MX529805A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |