MAUDE Adverse Event Report: MEDLINE - MEXICALI MEDLINE; CHEST/BREAST PACK

Catalog Number	DYNJ48682C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that when donning the surgeon, the gloves rip apart, very easily too.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
When donning the surgeon, the gloves rip apart, very easily too.

• Brand Name: MEDLINE
• Common Device Name: CHEST/BREAST PACK
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto #7; parque industrial; mexicali baja california 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25119250
• Report Number: 1423395-2026-00136
• Device Sequence Number: 13330139
• Product Code: OFG
• UDI-Device Identifier: 10195327442323
• UDI-Public: 10195327442323
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ48682C
• Device Lot Number: 25LMJ394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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
• Patient Sex: Unknown