| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PHILIPS AVENT NIPLETTE | NIPLETTE | PHILIPS ELECTRONICS UK LIMITED | HGY | SCF152/02 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-02-28 | 0 | 1. O |
Patient 1
ON (B)(6) 2013, CONSUMER STATES HER NIPPLE IS BLEEDING FROM USING THE NIPLETTE. AFTER NIPLETTE WAS REMOVED, ONE BREAST WAS RED AND SWOLLEN AND THE OTHER WAS BLISTERED AND BLEEDING. CONSUMER STATES SHE REC'D THE UNIT IN THE MAIL AND USED IT FOR AN HOUR OR TWO. THE NIPLETTE BECAME FULL WITH CLOUDY LIQUID AND BLOOD. CONSUMER VISITED THE DOCTOR AND WAS ASKED TO HAVE A MAMMOGRAM AND SEE A BREAST SPECIALIST.
Patient 1
ON (B)(4) 2013, CONTACTED THE CONSUMER. CONSUMER STILL HAS THE NIPLETTE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION. CONSUMER STATED SHE IS NOT PREGNANT AND DOES NOT HAVE ANY CHILDREN. ON (B)(6) 2013, CONSUMER WAS CONTACTED FOR ADD'L FOLLOW UP. THE NIPPLE HAS SCARING AND A PIECE OF TISSUE CAME OFF. DOCTOR ADVISED THAT SHE MIGHT HAVE DIFFICULTY BREAST FEEDING IN THE FUTURE. CONSUMER WAS GIVEN PAIN KILLERS AND WAS TOLD TO USE A HEATING PAD. CONSUMER WAS ALSO GIVEN AN ANTIBIOTIC OINTMENT. THE CONSUMER STATED SHE IS NO LONGER HAVING PAIN. THE BLEEDING TOO PROXIMATELY 1 1/2 TO STOP. THE CONSUMER HAS A CONDITION CALLED KELOIDS. THIS IS THE FIRST TIME THE CONSUMER HAS HAD THIS TYPE OF ISSUE. THIS IS THE FIRST USE OF THE NIPLETTE. CONSUMER STATED THEY ARE IN A WHEELCHAIR, BUT WOULD HAVE THE PRODUCT RETURNED FOR EVALUATION.
Patient 1
ON 11/11/2015 PRODUCT WAS RECEIVED AND INVESTIGATED. NO PRODUCT FAULTS WERE OBSERVED THAT COULD CAUSE THE REPORTED EVENT. THE NIPLETTES ARE FREE OF ANY SHARP EDGES, AND SUCTION WORKED AS EXPECTED.