MAUDE Adverse Event Report: AMEDA INC. AMEDA PURELY YOURS DOUBLE ELECTRIC BREAST PUMP; CUSTOM FIT FLANGES MEDIUM/LARGE

Catalog Number 17148P

Device Problem Scratched Material (3020)

Patient Problems Purulent Discharge (1812); Laceration(s) (1946); Injury (2348)

Event Date 02/01/2014

Event Type  Injury  

Event Description

Lactation consultant (lc) reported to ameda sales, a pt had an injury from 28.5mm insert.Lc gave pt inserts on (b)(6) 2014, pt experienced injury and antibiotics were started on (b)(6) 2014.Multiple attempts by ameda to contact pt were unsuccessful.On (b)(6) 2014, contacted mom who said " thought her skin was being pinched between insert and flange" after 4 uses; removed flange and insert; noted an injury; ran her finger along edge of insert and noted a sharp ridge of excess plastic.Pt's husband "torched the insert in an attempt to smooth it".Pt experienced sore nipples (unrelated to sharp ridge) and yellow pus in a cut; contacted uf lc to report flanges were cutting her and got replacements.Lc said she would make a report and advised pt to contact md due to yellow pus on cut area.Pt tc to md, who prescribed dicloxacillin via tc without examining pt.Pt reported the infection resolved w/full course of antibiotic and cut healed w/no lasting scars.Pt continues to pump w/ameda pump and hygienikit w/o subsequent issues.Ameda rec'd user facility (uf) medwatch on (b)(4) 2014.Ameda tc to (b)(4), uf biomedical eng., who said uf medwatch was not filed and would return suspect insert to ameda for evaluation.

Manufacturer Narrative

The testing and evaluation of the flange insert is completed.The inside rim edge has been melted and is deformed, ie.The pt's husband had "torched the insert in an attempt to smooth it".Due to the condition of the returned product, no conclusion can be made as to the cause of the event due to the returned product being manipulated.

• Brand Name: AMEDA PURELY YOURS DOUBLE ELECTRIC BREAST PUMP
• Type of Device: CUSTOM FIT FLANGES MEDIUM/LARGE
• Manufacturer (Section D): AMEDA INC.; 485 e half day rd ste 320; buffalo grove IL 60089 000
• Manufacturer Contact: joe boehm, dir ; 485 e half day rd ste 320; buffalo grove, IL 60089-0000 ; 8479642632
• MDR Report Key: 3824463
• MDR Text Key: 4393064
• Report Number: 3009974348-2014-00001
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 17148P
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR