MAUDE Adverse Event Report: CARDINAL HEALTH WINGS CHOICE PLUS QUILTED LG; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number	66034
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Codes	Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the polymer beads were outside the fluff layer of the brief, coming in contact with the skin and causing discomfort and irritation for the patients.
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the polymer beads were outside the fluff layer of the brief, coming in contact with the skin and causing discomfort and irritation for the patients.
Additional Manufacturer Narrative
A device history record could not be complete as the lot number provided by the customer is invalid for the reported product code.A product analysis was unable to be completed as to date no samples or pictures have been provided.Precluding any further information or evidence there is not enough information at this time to determine with any confidence what likely caused the reported issue; therefore, the root cause is undetermined.Based on the information available and the investigation findings, a risk assessment was conducted, and management personnel was made aware of the complaint details.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: WINGS CHOICE PLUS QUILTED LG
• Common Device Name: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): CARDINAL HEALTH; 525 north emerald rd; greenwood SC 29646
• Manufacturer (Section G): CARDINAL HEALTH; 525 north emerald rd; greenwood SC 29646
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13061947
• Report Number: 1033903-2021-00209
• Device Sequence Number: 17393235
• Product Code: EYQ
• UDI-Device Identifier: 20884527000682
• UDI-Public: 20884527000682
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 66034
• Device Catalogue Number: 66034
• Device Lot Number: 21287G191327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown