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

Model Number	0583
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	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer medco - louisiana reported quality issues with the basic hydrophobic small wound dressing kit (p/n 0583, lot 1596) and basic hydrophobic medium kit (p/n 0584, lot 1614); tubing was observed to pull apart or break at the stingray connection.Two additional units opened by the customer did not exhibit the same failure.Devices were not returned.No patient was reported to have been involved.Replacement product provided.Conservative determination: mdr reportable.
Additional Manufacturer Narrative
Pensar attempted to obtain the omitted information 1.Patient information (b)(6).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.

• Brand Name: PENSAR MEDICAL BASIC SERIES DRESSIGN 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: 25566391
• Report Number: 3007793449-2024-00003
• Device Sequence Number: 10077238
• Product Code: OMP
• UDI-Device Identifier: 00851978007221
• UDI-Public: 00851978007221
• 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
• Serviced by Third Party (Y/N): Unknown
• 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: 11/15/2025
• Device Model Number: 0583
• Device Catalogue Number: 8463540 0583
• Device Lot Number: 1613
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown