MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE MOLNLYCKE; BIOGEL

Model Number	41180-00
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported patient under evaluation in emergency department (ed) underwent left-side chest tube placement.Noted upon removal of resident's finger from chest, portion of glove tip was missing - estimated at 1x2cm (at largest).Wound flushed and then chest flushed with approximately 1l saline without glove piece being returned.Patient informed - note in chart.Unknown what led to issue - might have been caught on instrument in chest at time of insertion.The patient was sedated with local anesthetic during the procedure (chest tube placement).There was additional time spent irrigating the area to look for the glove fragment; however, the exact amount of time was not documented.As far as follow up treatment, options were shared with the patient and family at the time of disclosure.The patient chose to do ongoing monitoring vs additional surgical procedures.At this time there is no indication the glove was removed from the patient.Therefore, due to a lack of information regarding medical intervention, this complaint has been reassessed and classified as a serious event associated with use of a molnlycke product and is considered reportable to the us fda.We will reassess once/if additional information is received.

• Brand Name: MOLNLYCKE
• Common Device Name: BIOGEL
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5445 triangle parkway; peachtree corners GA 30047
• Manufacturer (Section G): MOLNLYCKE HEALTH CARE SDN. BHD; lot 9, lorong perusahaan 4; p.o box 52,; kulim, kedah 09000 ; MY 09000
• Manufacturer Contact: rachel gill ; 5445 triangle parkway; peachtree corners, GA 30047
• MDR Report Key: 23429623
• Report Number: 3004763499-2025-00012
• Device Sequence Number: 8252824
• Product Code: KGO
• UDI-Device Identifier: 07332551184834
• UDI-Public: 07332551184834
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K050184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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 Model Number: 41180-00
• Device Lot Number: 25C0008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male