MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE, US LLC DRESSING, MEPILEX (DRESSING,MEPILEX BORDER 4IN X 8IN #295800); DRESSING, WOUND, HYDROPHILIC

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

Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278); Blister (4537)

Event Date 09/28/2021

Event Type  No Answer Provided  

Event Description

Pt was started on cefpodoxime on (b)(6) 2021 for uti and presented to ed on (b)(6) 2021 due to c/o significant rash and pruritis.Symptom: skin rash, urticaria pruritus, blister.

• Brand Name: DRESSING, MEPILEX (DRESSING,MEPILEX BORDER 4IN X 8IN #295800)
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE, US LLC
• MDR Report Key: 12569353
• MDR Text Key: 274970041
• Report Number: MW5104353
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/29/2021

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR