MAUDE Adverse Event Report: NEOMEND INC -2953195 PROGEL PLEURAL AIR LEAK SEALANT; SEALANT, POLYMERIZING

Catalog Number	PGPS002
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Pulmonary Emphysema (1832); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient had subcutaneous emphysema post usage of progel.Based on the information provided, no conclusions can be made as to the degree to which the progel used in the procedure may have caused or contributed to the postoperative complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.".
Event or Problem Description
As reported, the surgeon responded to the sales rep's follow up on her experience using the product progel.The surgeon explained that during the summer in 2024 after use of progel she had a patient who post operatively experienced subcutaneous emphysema.The surgeon did not provide any more detail about the specific case.
Additional Manufacturer Narrative
As reported, the patient developed subcutaneous emphysema post usage of progel.The subject device was not returned for evaluation.The most probable cause me be the inadvertently clogging of a tube by the surgeon.Based on the information provided, no conclusion can be made as to what if any extent the progel caused or contributed to post operative subcutaneous emphysema.Addendum: h11: this supplemental mdr is submitted to correct the describe event or problem, imdrf annex e and imdrf annex b code.The adverse reactions section of the instructions-for-use, supplied with the device identifies subcutaneous emphysema as a possible complication.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, progel clogged a tube, and the patient ended up having significant subcutaneous emphysema.The surgeon explained that during the summer in (b)(6) 2024 after use of progel she had a patient who post operatively experienced subcutaneous emphysema.The surgeon did not provide any more detail about the specific case.

• Brand Name: PROGEL PLEURAL AIR LEAK SEALANT
• Common Device Name: SEALANT, POLYMERIZING
• Manufacturer (Section D): NEOMEND INC -2953195; 60 technology drive; irvine CA 92618
• Manufacturer (Section G): NEOMEND INC -2953195; 60 technology drive; irvine CA 92618
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 21211619
• Report Number: 1213643-2025-00017
• Device Sequence Number: 19785747
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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 Catalogue Number: PGPS002
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown