MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ MULTIPORE¿ SURGICAL TAPE; 3M MULTIPORE SURGICAL TAPE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Ulcer (2274); Localized Skin Lesion (4542)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Report received from (b)(6): skin flushing and ulceration occurred for a premature infant who underwent tracheal intubation ventilation that was affixed with 3m multipore dry surgical tape.The infant was (b)(6) age and in critical condition with breathing difficulty that required asphyxia resuscitation for 30 minutes.The infant was transferred from the obstetrics department to the neonatology department and was placed on a tracheal intubation ventilator.On the (b)(6) day of treatment, the symptoms developed where the tape was applied.The skin was thin and the tape was difficult to remove.The tape was removed by different methods but was torn.The tape was used for approximately 26 hours.Burn ointment was applied to the affected area, the skin was kept dry, and the area protected with hydrocolloid dressing.The skin ulcers improved with no adverse consequences.

Manufacturer Narrative

Patient identifier, weight: not provided.No samples were returned for analysis.A lot number was received.Limited information was provided regarding this case.It was reported that the patient's skin was thin, and the tape was difficult to remove.Application details for 3m multipore dry surgical tape were not provided.It is difficult to determine further that the cause of the incident is attributed to the 3m multipore dry surgical tape.It is unknown if additional products were used.Based on the information received, the causality of the skin damage is indeterminate.

Manufacturer Narrative

Updated brand name for tape.

Event Description

Report received from (b)(6): skin flushing and ulceration occurred for a premature infant who underwent tracheal intubation ventilation that was affixed with 3m multipore surgical tape.The infant was 27.5 weeks gestational age and in critical condition with breathing difficulty that required asphyxia resuscitation for 30 minutes.The infant was transferred from the obstetrics department to the neonatology department and was placed on a tracheal intubation ventilator.On the fourth day of treatment, the symptoms developed where the tape was applied.The skin was thin and the tape was difficult to remove.The tape was removed by different methods but was torn.The tape was used for approximately 26 hours.Burn ointment was applied to the affected area, the skin was kept dry, and the area protected with hydrocolloid dressing.The skin ulcers improved with no adverse consequences.

Manufacturer Narrative

B5, d1-d2: updated brand name for tape to 3m multipore surgical tape.C: marked "no" for combination product.H2: marked as correction.

Event Description

Report received from china: skin flushing and ulceration occurred for a premature infant who underwent tracheal intubation ventilation that was affixed with 3m multipore surgical tape.The infant was 27.5 weeks gestational age and in critical condition with breathing difficulty that required asphyxia resuscitation for 30 minutes.The infant was transferred from the obstetrics department to the neonatology department and was placed on a tracheal intubation ventilator.On the fourth day of treatment, the symptoms developed where the tape was applied.The skin was thin and the tape was difficult to remove.The tape was removed by different methods but was torn.The tape was used for approximately 26 hours.Burn ointment was applied to the affected area, the skin was kept dry, and the area protected with hydrocolloid dressing.The skin ulcers improved with no adverse consequences.

• Brand Name: 3M¿ MULTIPORE¿ SURGICAL TAPE
• Type of Device: 3M MULTIPORE SURGICAL TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M JAPAN PRODUCT LIMITED; 5500 ooaza-osanagi; higashine-shi; yamagata, 999-3 737; JA 999-3737
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 13233045
• MDR Text Key: 283747337
• Report Number: 2110898-2022-00003
• 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,Followup,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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: 2733-75
• Device Lot Number: 200102
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2021
• 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): Required Intervention
• Patient Age: 4 DA
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian