MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM DRESSING; TEGADERM¿ DRESSING

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Unspecified Infection (1930); Rash (2033); Skin Irritation (2076)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Gender information was provided for 3 out of 6 patients.Date of event: exact date of reported events was not provided.The events were reported on (b)(6) 2019 and this date was used for the date of the events.Initial reporter's occupation not provided.The cause of the reported skin reactions/infection could not be determined.The customer did not provide a sample(s) to 3m for analysis.Specific information was only provided for 3 out the 6 pts who reportedly experienced an adverse event.Further information was requested by 3m, however not provided.Manufacturing batch records were reviewed and found no manufacturing issues or process anomalies found that could relate to this issue.Retain product samples were inspected and did not contain any open seals.

Event Description

A hematology blood transfusion hospital in (b)(6) reported six pediatric patients (all ages and genders not provided) with a port-a-cath allegedly experienced skin irritation and possible infection.The hospital reported 1626w 3m¿ tegaderm¿ dressings were applied to protect the port-a-cath on each patient.Clabsi was alleged for two of the children, where a physician replaced the ports.No further details were provided on these two incidents.Open packaging of the tegaderm dressing was also reported.The hospital provided specific details on three patient incidents; a male pediatric patient developed skin redness after application of the referenced dressings to protect a port-a-cath.The alleged skin redness was reportedly 2cm x 2cm in size and occurred inside the dressing area on the chest.The skin redness appeared after 3-4 days of wear of the most recently applied dressing and resolved in one week.A second male pediatric patient developed a skin rash with itching after application of the referenced dressings to protect a port-a-cath.The alleged rash was reportedly 2cm x 2cm in size and occurred inside the dressing area on the upper chest.The rash appeared after 3-4 days of wear of the most recently applied dressing and resolved in one week.A third male pediatric patient developed blisters after application of the referenced dressings to protect a port-a-cath.The alleged blisters were reportedly within a 2cm x 2cm area and occurred inside the dressing area on the upper chest.The blisters appeared after 3-4 days of wear of the most recently applied dressing and resolved in one week.In all three cases the dressings were applied in contact with an open wound.Alcohol was used to prep the skin prior to application.The dressings were applied over a two-week period and were changed once per week.The patients had no known history of skin pathologies, sensitivities or allergies.The patients were changed to a new catheter.No further medical treatment was required.

• Brand Name: 3M TEGADERM DRESSING
• Type of Device: TEGADERM¿ DRESSING
• 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: dianne gibbs ; 275 5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8941503
• MDR Text Key: 155931826
• Report Number: 2110898-2019-00097
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 04001895928765
• UDI-Public: 04001895928765
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2020
• Device Model Number: N/A
• Device Catalogue Number: 1626W
• Device Lot Number: 2020-12 TJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2017
• 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): Required Intervention