MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DRAPE,SHEET,ECONOMY,40X58",ST,20/CS

Catalog Number	DYNJP2411
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Emotional Changes (1831); Impaired Healing (2378); Post Operative Wound Infection (2446)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025, "product was used as a sterile drape for a breast augmentation procedure." the facility reported, "the patient's left breast has been infected ever since the surgery and will require an additional surgery to clear the infection out." the facility further reported, "there has been ongoing medical care since the surgery" as a result of "delayed wound healing and non-healing with infection of implant on the left side." the facility stated, "the implant will need to be removed, the wound will need to be closed, and the implant replaced at later date." and "the patient has suffered injury to her breast during the infection." patient is "frustrated and angry." per the facility "the drape was used and discarded." no additional information regarding the customer reported incident is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2025, "product was used as a sterile drape for a breast augmentation procedure." the facility reported, "the patient's left breast has been infected ever since the surgery and will require an additional surgery to clear the infection out." the facility further reported, "there has been ongoing medical care since the surgery" as a result of "delayed wound healing and non-healing with infection of implant on the left side." the facility stated, "the implant will need to be removed, the wound will need to be closed, and the implant replaced at later date." and "the patient has suffered injury to her breast during the infection." patient is "frustrated and angry." per the facility "the drape was used and discarded.".
Additional Manufacturer Narrative
Updated d9: device available for evaluation and date returned to manufacturer.Updated h3: device evaluated by manufacturer.Updated h6: type of investigation (b).Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).Investigation confirms defect, product linked to recall.Recall was issued due to calibration of the equipment used to sterilize and package the devices.Sku dynjp2411 was listed as one of the affected items.However, the root cause of the infection could not be definitely determined.

• Brand Name: MEDLINE
• Common Device Name: DRAPE,SHEET,ECONOMY,40X58",ST,20/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24833226
• Report Number: 1417592-2026-00402
• Device Sequence Number: 13053511
• Product Code: PUI
• UDI-Device Identifier: 10080196745487
• UDI-Public: 10080196745487
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: Health Professional
• Device Catalogue Number: DYNJP2411
• Device Lot Number: 30524020226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-003
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White