MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW

Catalog Number 1668

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Skin Erosion (2075)

Event Date 05/23/2017

Event Type  Injury  

Event Description

Customer reported an outpatient with metastatic colon cancer had an implanted port located in her chest.The implanted port was accessed for an iv treatment of 5fu (chemotherapy).Cavilon no sting barrier film was reportedly applied to the site and then covered with a tegaderm iv transparent film dressing with adhesive free window.The patient went home and the infusion was scheduled to run for 46 hours.When the infusion finished, the outpatient removed the dressing and de-accessed the site.Two days after removal of the dressing, the patient reportedly experienced redness and blistering under the entire area where the tegaderm iv transparent film dressing and barrier film had been applied.The patient's therapy was reportedly held due to her skin condition and she was treated with oral antibiotics and an otc topical steroid cream.

• Brand Name: 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW
• Type of Device: TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: karen krenik, bsn ; 3m center building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517333091
• MDR Report Key: 6669828
• MDR Text Key: 78475217
• Report Number: 2110898-2017-00090
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2017

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?: No
• Device Operator: Nurse
• Device Catalogue Number: 1668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CENTRAL LINE PORT CATHETER; CHEMOTHERAPY INFUSION 5FU
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR