MAUDE Adverse Event Report: PENSAR MEDICAL PENSAR WOUNDPRO BASIC DRESSING AND CANISTER; NEGATIVE PRESSURE WOUND THERAPY, KITS AND CANISTERS

Model Number	0222
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	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) reported quality issues with the 300 cc canister p/n 0222, lot 1614 and basic hydrophobic medium dressing kit, p/n 0584, lot 1613).Units exhibited cracking and loose tubing connections.Canisters failed leak test when connected to the woundpro pump.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.A1-a6.Patient details.2.B6.Relevant test labs -n/a.3.B7.Other relevant history - n/a.4.D10.Date of concomitant therapy - unknown.The dressing and canister were opened and evaluated prior to use.The canister failed the test when placed into the woundpro npwt pump unit.Stingray connector for dressing was noted to have a crack/leak.Device(s) not returned for evaluation.This report is being submitted based on re-evaluation of reportability requirements per pensar capa 046.

• Brand Name: PENSAR WOUNDPRO BASIC DRESSING AND CANISTER
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY, KITS AND CANISTERS
• 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: 25566192
• Report Number: 3007793449-2024-00002
• Device Sequence Number: 9995613
• Product Code: OMP
• UDI-Device Identifier: 00851978007016
• UDI-Public: 851978007016
• 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): 05/18/2026

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: 0222
• Device Catalogue Number: 0222
• Device Lot Number: 1614
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• Is the Device Labeled for Single Use? (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
• Concomitant Medical Products and Therapy/Usage Dates: PENSAR WOUNDPRO NPWT PUMP.
• Patient Sex: Unknown