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

Model Number 66035

Device Problem Material Disintegration (1177)

Patient Problems Unspecified Infection (1930); Pain (1994); Anxiety (2328)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that their customer received the package of briefs and started using the product.They did not realize that the diapers were embedded with a hard, white, grainy, waxy substance that caused her to be rushed to the er with a vaginal infection.The substance from the diapers is embedded in her skin and all over her bed from use.Per additional information provided by the end-user on (b)(6) 2022, she was rushed to the er on (b)(6) 2022.She was fully treated in the er and was not admitted to the hospital.A ct scan was performed for observation to rule issues out.An iv was placed for the ct scan and the only medication given via the iv was 1mg of ativan and 4mg of morphine and whatever was used for contrast, there were no fluids given.For treatment she was prescribed a ten-day course of augmentin, diflucan, and topical lidocaine gel.She did not experience a fever.Both her heart rate and blood pressure were elevated but it was due to pain and anxiety.The substance she is referring to were hard-white balls that are present on the briefs prior to use.The substance can be seen as soon as the briefs are removed from the package which was not noticed prior to use.These hard white balls are still embedded in her skin to date.She stated that because she is bed-ridden she is unable to use a commode or toilet so to move her bowels her bed has to be lined with chucks and the briefs placed underneath her and in-between her legs, so the white hard balls were under her body while she laid on the part that goes in-between her legs for hours which left the substance embedded in her buttocks.When she was rolled over the upper part of the briefs where the tabs are was under her tummy for hours and the substance embedded in her tummy as well.The substance is still rising to the surface of her skin and then has to be picked out.She does not have any follow up care scheduled as she will not need any unless other issues arise.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint or samples.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.Two packages of samples were received at the manufacturing site for the investigation.The samples were analyzed, and the reported condition could not be confirmed; there were no issues observed with the product.All returned product was confirmed to meet manufacturing specifications.Management personnel has been made aware of this report.No further actions are required at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: WINGS CHOICE PLUS QUILTED XLG
• Type of Device: 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: 13524661
• MDR Text Key: 287262212
• Report Number: 1033903-2022-00210
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 66035
• Device Catalogue Number: 66035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female