MAUDE Adverse Event Report: CONVATEC INC L3W0500 - SUREPRESS; BANDAGE, ELASTIC

Model Number 650947

Device Problem Device Handling Problem (3265)

Patient Problems Hemorrhage/Bleeding (1888); Necrosis (1971); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Affiliation: (b)(6) clinic.Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported the "sure-press 650947 was applied to the left lower leg for +4 pitting edema / lymphadema.Ankle circumference is estimated at 25cm.The patient had strong pedal pulse and no further arterial studies were performed.The left leg did not have any wounds.The dressing was applied by the wound clinic nurse.Surepress absorbent padding 650948 was not used.The sure-press was covered with tubi-grip in an effort to help keep the dressing in place.The patient was sent home with his family and within 5-6 hours the patient was complaining of a high amount of pain.The son cut the sure-press dressing off and the patient was seen in the er.He was seen by a surgeon who diagnosed him with superficial necrosis.Petechial hemorrhage was present to the limb.The surepress was not reapplied.Beyond a week the patient required a left aka above the knee amputation.An autopsy on the amputated limb showed anterior vessels with 20% stenosis and posterior vessel with 90% stenosis.Patient was noted to have an ischemic reperfusion injury.A root cause analysis is being conducted." per additional information, the patient also had the "surepress (no padding) applied to his right lower extremity where he had a wound and received npwt negative pressure wound therapy.He had strong pulses to the right leg as well and suffered no untoward effects from the surepress.".

• Brand Name: L3W0500 - SUREPRESS
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15054925
• MDR Text Key: 296181441
• Report Number: 1049092-2022-00313
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 650947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Male