MAUDE Adverse Event Report: BIOLIFE, LLC STATSEAL DISC

Model Number DT013

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Skin Erosion (2075); Localized Skin Lesion (4542)

Event Date 11/10/2021

Event Type  Injury  

Event Description

Premature infant 22 4/7 weeks gestation, rds, breech delivery.Extreme prematurity with expected nutritional deficits expected.Npo on tpn/il at time of event.Left axillary picc was placed (b)(6) 2021.Patient was born on same day of picc.On (b)(6) 2021 rn was called to bedside to assess a peeling picc dressing along all edges due ro weeping of the skin and statseal disc appeared swollen.Upon removal of dressing, a pressure injury was noted underneath the statseal disc that exposed muscle tissue and tendon.Attending was called to beside to asses and instructed to redress line.Wocn evaluation on (b)(6) 2021 with braden qd of 17.Injury size 4x3x0.8 wound bed 90% moist non-granulation tissue; 10% yellow adipose tissue.Tendons and ligament visible.No undermining, and no tunnel/induration.Edges are well defined with a small amount sanguineous drainage.No sign of infection.Per wocn, wound is resolved on (b)(6) 2021.Patient remains hospitalized as of (b)(6) 2022, unrelated to injury associated with the statseal disc.

• Brand Name: STATSEAL DISC
• Type of Device: STATSEAL DISC
• Manufacturer (Section D): BIOLIFE, LLC; 8163 25th court east; sarasota FL 34243
• Manufacturer (Section G): BIOLIFE, LLC; 8163 25th court east; sarasota FL 34243
• Manufacturer Contact: claudia masselink ; 8163 25th court east; sarasota, FL 34243 ; 9413601300
• MDR Report Key: 15306511
• MDR Text Key: 298766626
• Report Number: 1066421-2022-00003
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 130324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DT013
• Device Catalogue Number: DT013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 DA
• Patient Sex: Male