MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BANDAGE, PLASTIC,CURAD,2"X4",10CT

Catalog Number CUR47437RB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer she placed a bandage on her lower arm near the elbow and when she took the bandage off 'less than 24 hours later, the bandage took off the skin'.The customer reported that the area was 'all green' and the customer went to the urgent care where she was prescribed antibiotics.The sample was returned but a definitive root cause could not be determined at this time.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer she placed a bandage on her lower arm near the elbow and when she took the bandage off 'less than 24 hours later, the bandage took off the skin'.

• Type of Device: BANDAGE, PLASTIC,CURAD,2"X4",10CT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15897501
• MDR Text Key: 304680718
• Report Number: 1417592-2022-00233
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CUR47437RB
• Device Lot Number: 19054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention