MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION COLD SPRINGS DEPEND UNDERGARMENTS; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number MAXIMUM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Itching Sensation (1943); Rash (2033)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

Consumer's spouse called to report that her husband put on a depend from a new package and the next morning, he developed a rash around his waist and two hours later the rash spread to his groin.He took off depend and took a shower.The rash was itchy with red hives and spread to his entire body.He went to er, his blood pressure was low due to dehydration from diarrhea and possibly from rash.He was given fluids, (b)(6) was given by mouth, methylprednisone (pf) was given as an injection, and he received intravenous fluids consisting of sodium chloride 0.9% iv at the er and was discharged home six hours later.His symptoms improved but the hives returned two days later.He went to the er again and was admitted to the hospital for one night.He followed up with an allergist.The only allergy found was to brazil nuts.The rash has resolved and he was doing well now.

• Brand Name: DEPEND UNDERGARMENTS
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION COLD SPRINGS; 1050 cold spring rd.; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION COLD SPRINGS; 1050 cold spring rd.; neenah WI 54956
• Manufacturer Contact: chris maertz ; 2100 winchester road; neenah, WI 54956 ; 9207214907
• MDR Report Key: 8552750
• MDR Text Key: 143227344
• Report Number: 2184163-2019-00002
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MAXIMUM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 66 YR