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 Local Reaction (2035); Localized Skin Lesion (4542)

Event Date 11/03/2022

Event Type  Injury  

Manufacturer Narrative

Information not provided.No sample was received for analysis.3m will continue to monitor.End of report.

Event Description

Received from china: a patient who was admitted to the neurology department for treatment due to nervous convulsions received an injection of medication and the needle was then removed needle and skin damage with continued bleeding was alleged where 3m transpore white surgical tape was applied.Wound hemostasis was performed, and a dressing was used on the wound, which was changed daily, and hospitalization was prolonged.

• 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; manufacturing medical devices; edisonstrasse 6; kamen, 59174 ; GM 59174
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15810546
• MDR Text Key: 303794082
• Report Number: 2110898-2022-00118
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 30707387525911
• UDI-Public: 30707387525911
• 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: Physician
• Type of Report: Initial
• Report Date: 11/16/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1534-0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian