MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ TRANSPORE¿ WHITE SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number N/A

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

Patient Problems Erythema (1840); Fluid Discharge (2686)

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

A1, a4: not provided.H10: a sample was not available for return for analysis.A lot number was provided and no issues were identified in the production history.It is not possible to definitively determine the root cause.3m will continue to monitor.

Event Description

Received from china: a neonatal patient developed a raised area of erythema with pus (an area about 1.5 × 2cm in size) after 3m transpore white surgical tape was applied to the middle of the forehead to mark the name of the patient.After hospital admission.The symptoms were observed during bathing.Muprocin ointment was applied.The patient had been admitted to the hospital for vomiting, shortness of breath, and cyanosis for 10+minutes and was given symptomatic rescue treatment that included sputum aspiration, box type oxygen inhalation, continuous electrocardiogram, and percutaneous oxygen saturation monitoring.The hospital admission was not due to 3m transpore white surgical tape.

• Brand Name: 3M¿ TRANSPORE¿ WHITE SURGICAL TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH WERK KAMEN; edisonstrasse 6; 59174 kamen; kamen, ; GM
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17144602
• MDR Text Key: 317338562
• Report Number: 2110898-2023-00048
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1534-0
• Device Lot Number: 104311089
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 7 DA
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian