MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DBD-DG HEALTH,BANDAGE,STRONG STRIP,60CT

Catalog Number DG18003

Device Problem Product Quality Problem (1506)

Patient Problem Tissue Breakdown (2681)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "bandages are causing sores." reported medical intervention sought.It was reported, "bandages are causing sores." reply email received by end user marque blubaugh on 8/9/2021 that states, "still getting treated.When i feel better, i will reply.Cant right now.Just went to wound center." end user states, "i will present as soon as information is conformed and available." due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.It is unknown if samples are available for return and evaluation.Therefore, a true root cause will be difficult to determine.Due to the reported incident, reported medical intervention and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.

Event Description

It was reported, "bandages are causing sores." reported medical intervention sought.

Manufacturer Narrative

Supplemental mdr filed on 8/18/2021 to reflect corrected/change made in d2, product code changed from fro to kgx per division qa m.S.8/18/2021.

Event Description

It was reported, "bandages are causing sores." reported medical intervention sought.

• Type of Device: DBD-DG HEALTH,BANDAGE,STRONG STRIP,60CT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12322239
• MDR Text Key: 268058662
• Report Number: 1417592-2021-00152
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DG18003
• Device Lot Number: 90920060001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/14/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention