MAUDE Adverse Event Report: MEDELA, INC. SOFTSHELLS, INVERTED NIPPLES

Model Number 80220

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/15/2014

Event Type  Injury  

Event Description

The customer reported to customer service that her nipples were staying moist and not allowing for them to dry, while using the soft shell inverted nipple.

Manufacturer Narrative

Replacement softshell were sent to the customer.A medela clinician followed up with the customer who found soft shells for inverted nipples did not meet her needs because moisture was trapped and irritation increased.Customer states she received medical attention from dermatologist who diagnosed thrush and treated both mother and baby; both are not recovered and issue is resolved.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusions can be made as to the cause ot the event.It cannot be definitively concluded that the softshell caused or contributed to the customers thrush.Reported issues with thrush are under investigation (b)(4).Should additional information or the original product be received, resulting in new, changed, or correct information, a follow up report will be filed at that time.See scanned page.

• Brand Name: SOFTSHELLS, INVERTED NIPPLES
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 3642032
• MDR Text Key: 17616179
• Report Number: 1419937-2014-00161
• Device Sequence Number: 1
• Product Code: HFS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 80220
• Device Catalogue Number: 80220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/15/2014
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1