N
Patient 1
PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER, THEREFORE, UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME.
MAUDE MDR 6247636
- MDR report key
- 6247636
- Report number
- 3004443383-2017-00001
- Event key
- 0
- Event type
- 3
- Date received
- 2017-01-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MGR. REGULATORY FEMININE CARE
- Address
- 6110 CENTER HILL AVENUE CINCINNATI OH 45224 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TAMPAXTAMPONSPEARL | TAMPON, MENSTRUAL, UNSCENTED | HYGINETT HUNGARIAN AMERICAN CO | HIL | NOT AVAILABLE | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-12 | 0 | 1. O; 2. R |
Event Narratives#
D
Patient 1
FIBROMA - VAGINA [FIBROMA]; DISCOMFORT IN LOWER PORTION OF VAGINA [VULVOVAGINAL DISCOMFORT]; PAIN AROUND TAMPON CORD [MEDICAL DEVICE SITE PAIN]; DISCOMFORT - FROM TAMPON [MEDICAL DEVICE SITE DISCOMFORT]; PAIN - VAGINA [VULVOVAGINAL PAIN]; NOTICED A SMALL INJURY, SOMETHING LIKE A SCRATCH OR FISSURE - VAGINA [VULVOVAGINAL INJURY]; INJURY - TAMPON AREA [MEDICAL DEVICE SITE INJURY]. CASE DESCRIPTION: THE CONSUMER, A FEMALE OF UNSPECIFIED AGE, REPORTED VIA E-MAIL ON 13-DEC-2016, THAT SHE USED TAMPAX TAMPONS PEARL BEGINNING ON AN UNSPECIFIED DATE AND EXPERIENCED THE FOLLOWING SYMPTOMS BEGINNING ON AN UNSPECIFIED DATE: SMALL INJURY (SOMETHING LIKE A SCRATCH, A FISSURE), FEELING SOME DISCOMFORT IN THE LOWER PORTION OF VAGINA, AND STRONG PAIN AROUND THE TAMPON CORD DURING MENSTRUATION. THE CONSUMER WENT TO HER DOCTOR AND IT SEEMED LIKE A SMALL TEAR AND SHE COULD NOT FIGURE OUT HOW IT HAPPENED. THE CONSUMER SWITCHED BACK TO THE REGULAR TAMPAX AND ALL OF HER AILMENTS WENT AWAY. SHE VISITED A GYNECOLOGIST WHO TOLD HER IT WAS A SMALL FIBROMA WHICH HAD TO BE REMOVED AND SENT FOR BIOPSY. TREATMENT: HAD TO UNDERGO TWO SMALL SURGERIES. THE CONSUMER WENT BACK TO USING THE TAMPAX TAMPONS PEARL AGAIN AND WITHIN TWO OR THREE CYCLES AND SHE HAD A NEW INJURY. SHE REPORTED THAT THE GYNECOLOGIST FORBID HER FROM USING THEM BECAUSE HE THOUGHT THE PROBLEM HAD BEEN CAUSED EXCLUSIVELY BY USING TAMPAX. SHE HAD USED THE PRODUCT REGULARLY OF A NUMBER OF YEARS. THE CONSUMER HAD PREVIOUSLY USED COMPACT TAMPAX WITH APPLICATOR AND THE "REGULAR ONES" (THOSE THAT HAVE A COTTON CORD) WHICH CAUSED NO INJURIES TO HER. ALLERGIES: LATEX AND OTHER PRODUCTS CONTAINING CELLULOSE, AS WELL AS SOME FEMININE PADS THAT USE THEM IN THEIR PRODUCTS OR PROCESSING. CONCOMITANT PRODUCT(S): NONE REPORTED. THE CASE OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.