MAUDE Adverse Event Report: PENSAR MEDICAL PENSAR MEDICAL MICRODOC DRESSING KIT; NEGATIVE PRESSURE WOUND THERAPY KIT

Model Number	4003
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pensar attempted to obtain the omitted information: 1.Patient information a1-a6.2.B6 relevant test labs - n/a.3.B7 other relevant history -n/a.4.D10 date of concomitant therapy - unknown.The complaint was received as a result of a sealing issue.Leak and/or seal issues are a commonly known risk for all negative pressure wound therapy devices.No documentation of any harm or impact to patient.As device was not returned for evaluation, additional testing was not performed.After additional conversations with clinical staff to best practices of obtaining and maintaining appropriate seal with the device the usage appears to have been remedied.Additional product provided to the distributor/user as replacement.This report is being submitted based on re-evaluation of reportability requirements per pensar capa 46.
Event or Problem Description
Customer (b)(6) reported potential quality issues with the microdoc wound dressing (p/n 4013 (system p/n 4003, lot 20250120)); the dressing was reported as having a leak.Customer staff provided additional application training to best practices in avoiding leaks through adhesive dressing application.Patient(s) required a new wound dressing.Devices were not returned.Replacement product provided.Conservative determination: mdr reportable.

• Brand Name: PENSAR MEDICAL MICRODOC DRESSING KIT
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY KIT
• Manufacturer (Section D): PENSAR MEDICAL; 109 n post oak ln; suite 525; houston TX 77024
• Manufacturer (Section G): PENSAR MEDICAL; 109 n post oak ln; suite 525; houston TX 77024
• Manufacturer Contact: jon olson ; 109 n post oak ln; suite 525; houston, TX 77024 ; 2142881035
• MDR Report Key: 25577893
• Report Number: 3007793449-2024-00010
• Device Sequence Number: 8975262
• Product Code: OMP
• UDI-Device Identifier: 00851978007528
• UDI-Public: 00851978007528
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K200223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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 Model Number: 4003
• Device Catalogue Number: 8463550 4003
• Device Lot Number: 20250120
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICRODOC NEGATIVE PRESSURE WOUND THERAPY DEVICE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown