MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS, LP TAPE AND BANDAGE, ADHESIVE

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Urticaria (2278)

Event Date 03/08/2024

Event Type  Injury  

Event Description

The reporter stated she was having allergic reaction from the dressing that was used on her.She said she has the same kind of reactions three times from the same type of dressing manufactured by centurion.She said after the application of the dressing there was a 20-minute lag, and she started experiencing itching.The second time, the same thing happened.She said the third time the itching was all over the place and her skin became puffy, red, sore and hives were all over.She said she had allergic reactions from bard's statlock adhesive a long time ago.Ref report: mw5152647, mw5152648.

• Brand Name: TAPE AND BANDAGE, ADHESIVE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS, LP
• MDR Report Key: 18886481
• MDR Text Key: 337617618
• Report Number: MW5152646
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic