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

Model Number	0584
Medical Device Problem Codes	Material Separation (1562); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
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 dressings were opened and evaluated prior to use.The tubing was noted to be pulling apart from the connector onn some product.Product is supplied as 10 each per case.Other product in the case was noted as not exhibiting the same issue.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 medco - reported quality issues with the basic hydrophobic medium wound dressing kit (p/n 0584, lot 1616); tubing was observed to pull apart or break at the stingray connection.Two units observed with the potential defect of a case of (b)(4) each devices.Devices were not returned.No patient was reported to have been involved.Replacement product provided.Conservative determination: mdr reportable.

• Brand Name: PENSAR MEDICAL BASIC SERIES 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: 25566519
• Report Number: 3007793449-2024-00004
• Device Sequence Number: 13265169
• Product Code: OMP
• UDI-Device Identifier: 00851978007238
• UDI-Public: 00851978007238
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K150960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare 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 Expiration Date: 04/10/2026
• Device Model Number: 0584
• Device Catalogue Number: 8463540 0584
• Device Lot Number: 1616
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 06/19/2026
• 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: PENSAR WOUNDPRO NPWT PUMP; PENSAR WOUNDPRO NPWT PUMP.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown