MAUDE Adverse Event Report: Medline Industries, LP Curad; BANDAGE,SHEER,CURAD,ASSORTED,80EA/BX

Catalog Number	CUR45243RB
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Codes	Pain (1994); Skin Burning Sensation (4540); Skin Disorders (4543); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, a bandage was used after receiving a b12 injection in the customer's right hip.About 23 hours later, the customer felt irritation and soreness in the area under the bandage.Customer showered and removed the wet bandage, and in doing so, the skin on both adhesive areas came off with the bandage.
Additional Manufacturer Narrative
According to the customer, a bandage was used after receiving a b12 injection in the customer's right hip.About 23 hours later, the customer felt irritation and soreness in the area under the bandage.Customer showered and removed the wet bandage, and in doing so, the skin on both adhesive areas came off with the bandage.The raw skin was extremely painful, like a "raw nerve ending or burn pain." customer states just the slightest touch of clothing or any pressure was too painful.It took 2 weeks to heal.Customer has never had any problems, nor has skin diseases or issues.No additional information at this time.There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Curad
• Common Device Name: BANDAGE,SHEER,CURAD,ASSORTED,80EA/BX
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50129936
• Report Number: 1417592-2026-08241
• Device Sequence Number: 14871561
• Product Code: KGX
• UDI-Device Identifier: 00080196302935
• UDI-Public: 00080196302935
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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 Catalogue Number: CUR45243RB
• Device Lot Number: 250201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown