MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50 L3C2250 - UNO OR/WOUND DRAINAGE; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number 40101181

Device Problem Suction Problem (2170)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

It was reported "that handyvac does not hold vacuum.All connections were checked and secured but the vacuum still "discharged" too fast.This caused hematoma to develop on surgery site for back surgery patient.Another surgery was required to remove the coagulated blood.When asked about use of clamps, complainant said that both clamps were closed upon squeezing the bellows.After wound closure bellows were attached to drain tubing, both clamps were opened and left open.".

Manufacturer Narrative

Annex f: updated annex f from f26 to f23.

• Brand Name: L3C2250 - UNO OR/WOUND DRAINAGE
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts ; BO
• Manufacturer (Section G): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts ; BO
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 13660032
• MDR Text Key: 286519997
• Report Number: 3007966929-2022-00001
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 40101181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1