MAUDE Adverse Event Report: STATLOCK PICC PLUS ADJ POST; CENTRAL VENOUS CATHETER DRESSING CHANGE

Device Problem Fitting Problem (2183)

Patient Problems Tissue Breakdown (2681); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Patient's father reported that the patient was discharged from the hospital only a few days ago and that it was too early to tell if the adempas has caused any worsening or improvement in his condition since the discharge.Exact dates/length of stay of hospitalization and cause unknown.He also reported that the patient has been off tadalafil since prior to starting adempas.Pt has been experiencing spontaneous erections.Father stated that there is some breakage in the skin on the patient's penis due to friction so they have applied some neosporin to the area.Father also complained that the statlock that they received from cvs did not fit.He did not report that the stat:lock caused any clinical injuries.Unknown if the doctor is aware of any of the issues reported above.Iv remodulin pt.Patient actively taking remodulin/adempas.Did the pt miss a dose or experience an adverse event as a result of the defective product? no; defective product lot number and expiration date are both unk.Does the pt have the defective product on hand for possible return to the mfr? unk.Reported to cvs/caremark by pt/caregiver.

• Brand Name: STATLOCK PICC PLUS ADJ POST
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE
• MDR Report Key: 17254691
• MDR Text Key: 318464410
• Report Number: MW5119101
• Device Sequence Number: 1
• Product Code: PEZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2023
• Patient Sequence Number: 1
• Treatment: ADEMPAS; NEOSPORIN ; REMODULIN
• Patient Sex: Male