FDA Adverse Event Injury Summary report: N

BREASTPUMP PNSA STARTER

MDR report key: 7872278 · Received September 13, 2018

Report

Report Number: 1419937-2018-00202
Event Type: Injury
Date Received: September 13, 2018
Date of Event: August 20, 2018
Manufacturer: MEDELA LLC
Product Code: HGX
PMA / PMN Number: K031614
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING INSPECTING THE FACEPLATE AND BACK PLATE FOR DAMAGE; INSPECTING AND CLEANING THE DIAPHRAGM; DISASSEMBLING, INSPECTING, CLEANING AND REASSEMBLING THE KIT AND TUBING SET; AND VERIFYING BREAST SHIELD FIT. DURING TROUBLESHOOTING, THE CUSTOMER ALLEGED THAT SHE HAD MULTIPLE BLOCKED DUCTS AND THAT THE TUBING WAS NOT FITTING PROPERLY ONTO THE FACEPLATE. REPLACEMENT TUBING WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2018, THE CUSTOMER INDICATED VIA EMAIL THAT SHE WAS PRESCRIBED AN ANTIBIOTIC AND THAT SHE RECEIVED THE NEW TUBING, BUT THE PUMP SUCTION WAS STILL LOW, THOUGH THE CLOGGED DUCTS WERE RESOLVED. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS, INCLUDING IN WRITING, ENCOURAGING HER TO CONTACT CUSTOMER SERVICE TO HELP COME TO RESOLUTION OF HER ISSUE, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

Description of Event or Problem · 1

ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS "NOT WORKING LIKE IT USED TO" AS IT DID NOT HAVE ENOUGH SUCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
715945	BREASTPUMP PNSA STARTER	PUMP, BREAST, POWERED	HGX	MEDELA LLC	57081	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other