MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CURAD; BANDAGE,ADHSV,FABRIC,CURAD,ASSTD,100/BX

Model Number	CUR0700RB
Health Effect - Clinical Code	Rash (2033)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported end-user developed a "square/rectangle rash/red area where the white absorbent bandage pad was." email received from end user's father, who provided additional information in regards to this incident.Reporter states, "placed a curad bandage on a very mild superficial wound 1/25/21, upon removal on 1/29/21 the area under the white pad was observed to be extremely red." reporter further described the skin reaction as, "very red, in the exact shape of the white pad, no discharge, no heat, no pain." reporter states, end-user has used the product in the past and "and no reactions were observed or experienced." reporter states, end-user has no allergies.Reporter states, on (b)(6) 2021 he took end-user to woodinville pediatrics, woodinville wa 98072 to see a physician who prescribed a steroid topical anti-inflammatory (triamcinolone acetonide 0.1% topical ointment applied twice daily).Reporter states, "red area is now completely normal as of 2/15/21." samples are available for return and have been requested for return and evaluation.No further information is available.Due to the reported incident, medical intervention 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 or Problem Description
It was reported end-user developed a "square/rectangle rash/red area where the white absorbent bandage pad was.".
Additional Manufacturer Narrative
Changed/additional information added.D9 device available for evaluation -no.G6 type of report - follow-up.H3 device evaluated by manufacturer - no, not returned to the manufacturer.H2 if follow-up what type? additional information.H6 type of investigation- 4109, 4114.H5 investigation conclusion - 67, cause/ zcd00006/unconfirmed defect.H10 investigation report reads as follows, 3/1/2021.Investigation summary: "no sample was provided for evaluation of the concern.Adhesive does react to each person's skin differently.Variable conditions such as temperature, humidity, and length of wear may also affect the bandage, causing the issue experienced.Our adhesive levels are monitored throughout the manufacturing process to ensure a consistent product and every lot is tested for adhesive strength and weight.Based on this the issue cannot be confirmed.The complaint history was reviewed and this is the first complaint of this nature on this item.We will continue to monitor the issue and provide corrective action as needed.".
Event or Problem Description
It was reported end-user developed a "square/rectangle rash/red area where the white absorbent bandage pad was.".

• Brand Name: CURAD
• Common Device Name: BANDAGE,ADHSV,FABRIC,CURAD,ASSTD,100/BX
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11338027
• Report Number: 1417592-2021-00021
• Device Sequence Number: 14462461
• Product Code: KGX
• UDI-Device Identifier: 00080196326160
• UDI-Public: 00080196326160
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: CUR0700RB
• Device Catalogue Number: CUR0700RB
• Device Lot Number: 20051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Weight: 32