MAUDE Adverse Event Report: EVENFLO FEEDING INC. EVENFLO FEEDING INC.; ADVANCED DOUBLE ELECTRIC BREAST PUMP

Model Number 516511

Device Problem Increase in Suction (1604)

Patient Problem Unspecified Infection (1930)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

Evenflo assessed this report based on the consumer-provided information alone, as the product involved in the complaint was not returned for further investigation.Accordingly, the company is unable to determine if the product was operating within specification or simply did not meet the consumer's expectations for vacuum.Notwithstanding the lack of information to determine if a malfunction occurred, evenflo is notifying the fda because the available information reasonably suggests that a reportable event has occurred.The consumer developed mastitis during the timeframe she was using the pump and was subsequently treated with antibiotics, although whether the pump caused or contributed to the condition is undetermined.Mastitis is usually a benign and self-limiting infection, but when antibiotics are needed to treat the condition the potential for permanent injury is present.The company learned from the consumer that she allegedly had engorgement prior to developing mastitis.Engorgement is not unusual in women who breastfeed or use an electric pump and is a temporary condition in the vast majority of instances, relieved via breastfeeding, hand expression or other available pumping device.Failure to relieve the engorgement with one of these methods may have caused the development of mastitis as well.Moreover, if the consumer was dissatisfied with the level of vacuum on the pump, it is reasonable to expect her to discontinue use.Evenflo does not have information to suggest that a malfunction of the pump led to the mastitis, but the medical intervention and use of antibiotics rendered the event reportable.Should additional information be received, resulting in new, changed, or corrected information to this report, a follow up report will be submitted.

Event Description

The customer reported on (b)(6) 2016, that her advanced double electric breast pump would not generate a vacuum level suitable for milk expression.The customer reported that she has developed mastitis and was prescribed an antibiotic by her physician.

• Brand Name: EVENFLO FEEDING INC.
• Type of Device: ADVANCED DOUBLE ELECTRIC BREAST PUMP
• Manufacturer (Section D): EVENFLO FEEDING INC.; 9277 centre pointe drive; suite 160; west chester OH 45069
• Manufacturer (Section G): SOLSTICE TECHNOLOGIES LIMITED; 2303 alliance building; 133 connaught road central; sheung wan, hk-na hong kong, china 0000 ; HK 0000
• Manufacturer Contact: wade halma ; 9277 centre pointe drive; suite 160; west chester, OH 45069 ; 5138701629
• MDR Report Key: 5501611
• MDR Text Key: 40703110
• Report Number: 3009826814-0216-00001
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 516511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other