MAUDE Adverse Event Report: Medline Industries, LP Medline; CAP,BOUFFANT,SPUNBOND,BLUE,24"

Catalog Number	CRI1004
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer contact on (b)(6) 2026, "there have been 10 reported incidents of allergic reactions" and "allergic reactions have been described as red non-raised rash encircling the scalp area.".
Additional Manufacturer Narrative
According to the customer contact on (b)(6) 2026, "there have been 10 reported incidents of allergic reactions" and "allergic reactions have been described as red non raised rash encircling the scalp area." the customer contact stated, "bouffant caps have been noted to causing red irritation marks on patients' heads, more so on bald(ing) individuals." per the customer contact, "the bouffant is worn only for pacemaker procedures in the unit" and "it was on the patient's head while patient was being prepped for surgery." it was reported, "several minutes after the patient donned the bouffant, redness and irritation was noted on the scalp and was noted to be tracking down toward the eyes." the customer contact reported, "benadryl was administered "[25mg iv]"" and "patient was treated for allergic reaction following standard protocol." per the customer contact, no injuries were reported as a result of the reported incident.No additional information is available at this time.A sample has been requested for evaluation.It has been determined that though the event did not involve a death or serious injury, recurrence 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: Medline
• Common Device Name: CAP,BOUFFANT,SPUNBOND,BLUE,24"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50276599
• Report Number: 1417592-2026-08850
• Device Sequence Number: 18580107
• Product Code: FYF
• UDI-Device Identifier: 10080196745777
• UDI-Public: 10080196745777
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CRI1004
• Device Lot Number: 34826030001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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