MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD DRESSING PRIMAPORE 4"X3 1/8"; TAPE AND BANDAGE, ADHESIVE

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2022

Event Type  malfunction  

Event Description

Spontaneous communication from pts daughter.She is trying to have the rn help place site but its not sticking.They have tired it 14 times (not sure why she is not able to get it to stay).Remodulin dose/directions: fill 3ml cartridge as instructed and infuse continuously per physician titration orders outlined on dosing sheet.Allow for priming volume and safety factor volume.Dosing range: min 1 ng/kg/min to max 150 ng/kg/min.Did the patient miss a dose or experience an ae because of the defective product? unknown.Does the pt have the defective product on hand for possible return to the manufacturer? unknown.Reported to (b)(6) by pt/caregiver.

• Brand Name: DRESSING PRIMAPORE 4"X3 1/8"
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD
• MDR Report Key: 14623488
• MDR Text Key: 293613272
• Report Number: MW5110148
• Device Sequence Number: 2
• Product Code: KGX
• Combination Product (y/n): Y
• 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: 05/21/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female