FDA Adverse Event Injury Summary report: N

PURELY YOURS

MDR report key: 4864848 · Received June 23, 2015

Report

Report Number: 3009974348-2015-00125
Event Type: Injury
Date Received: June 23, 2015
Date of Event: March 3, 2014
Report Date: March 4, 2014
Manufacturer: AMEDA, INC.
Product Code: HGX
PMA / PMN Number: K973501
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

PRODUCT WAS EVALUATED FOR EVIDENCE OF ALLEGATION. THE RETURNED AMEDA PURELY YOURS BREAST PUMP MET AMEDA SPECIFICATIONS FOR BOTH SUCTION AND SPEED, AND PASSED VISUAL INSPECTION STANDARDS. NO EVIDENCE OF MALFUNCTION WAS OBSERVED.

Description of Event or Problem · 1

AS PART OF AMEDA, INC.'S QUALITY MANAGEMENT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACTED AMEDA, INC ON (B)(6) 2014 TO REPORT LOW SUCTION WHILE USING THE PURELY YOURS BREAST PUMP. CUSTOMER USES THIS PUMP EXCLUSIVELY TO EXPRESS HER BREAST MILK SINCE BABY DOES NOT DIRECTLY NURSE. CUSTOMER REPORTS BREASTS NEVER FEEL DRAINED AND ARE LEFT FULL OF MILK AFTER PUMPING. CUSTOMER SOUGHT MEDICAL ADVICE FOR UNILATERAL LEFT BREAST MASTITIS ON (B)(6) 2014. CUSTOMER WAS PRESCRIBED A 10 DAY COURSE OF ORAL ANTIBIOTICS AND RENTED A HOSPITAL GRADE BREAST PUMP TO RESOLVE THE BREAST INFECTION. CUSTOMER WAS HOSPITALIZED FOR 24 HOURS ON (B)(6) 2014, 2 DAYS AFTER STARTING ORAL ANTIBIOTICS DUE TO POOR RESOLUTION OF MASTITIS INFECTION ON THIS MEDICATION. CUSTOMER WAS ADMINISTERED INTRAVENOUS ANTIBIOTICS AND FLUIDS TO RESOLVE INFECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
407540	PURELY YOURS	ELECTRIC BREAST PUMP, 884.5160	HGX	AMEDA, INC.	24502082

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| O