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

Model Number	1839-2100
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient alleged anaphylaxis after use of 3m¿ tegaderm¿ picc/cvc securement device + i.V.Advanced securement dsg, 1839-2100.The patient reported trouble breathing requiring administration of a epipen®.Per patient they did not infuse medication that day; unknown if md was aware or the medication specifics.Indication was reported for selective deficiency of immunoglobulin g(igg) sub classes.Patient specifics and medical history are not available.No further information.
Additional Manufacturer Narrative
Date of event is unknown.Lot number and expiration date is unknown.Device manufacture date unknown.In accordance with 21 cfr 803 report number mw5108514 was received through fda's medwatch program.Device is not available for evaluation.3m¿ will continue to monitor.

• Brand Name: 3M¿ TEGADERM¿
• Common Device Name: 3M¿ TEGADERM¿
• 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: 14210204
• Report Number: 2110898-2022-00033
• Device Sequence Number: 19942316
• Product Code: KMK
• UDI-Device Identifier: 00707387769543
• UDI-Public: 00707387769543
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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
• Operator of Device: Other
• Device Model Number: 1839-2100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown