MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ TEGADERM¿; 3M(TM) TEGADERM(TM) +PAD FILM DRESSING

Model Number	3584
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	07/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: the device was not returned to 3m; therefore, an evaluation of the device was not performed.The dressing contains acrylates in it's adhesive.A small population of people are known to be allergic to acrylates and may result in a mild discomfort to a rash.If the medical dressing is applied under tension or if swelling occurs at the injury site, it is possible that a blister or rash could result.The mother reported using an unidentified dressing for the first two days prior to the 3m tegaderm.The four days of daily dressing changes may have also made the facial skin more sensitive.An investigation into the subject lot was performed.There have been no other reports of this product lot being involved in any other alleged injury reports to date.The photos that were provided of the wound site show signs of trauma around the entire area of the wound, not just the area around the adhesive border which indicates that the redness may be caused by something other than the adhesive.The instructions for use that accompanies the 3m tegaderm dressings provides important safety information.Refer to the specific product packaging and instructions for use for proper application and removal technique.Prepare the site according to your facility's protocol.Allow all preps and protectants to dry completely before applying the dressing.Application: do not stretch the dressing as tension can cause skin trauma.Removal: gently grasp an edge and slowly peel the dressing from the skin in the directions of hair growth.Avoid skin trauma by peeling the dressing back, rather than pilling it up from the skin.3m will continue to monitor field performance of this device.
Event or Problem Description
A 3m representative reported on behalf of the customer, the mother of a female pediatric customer alleged inflammation on the child's chin after use of 3m¿ tegaderm¿ + pad film dressing.The mother reported her daughter sustained a cut on her chin that required a clinician consultation.The physician cleaned the wound with normal saline, secured the skin injury with an unidentified brand of steri-strips and applied tape over it.The following day the dressing came off and they followed up with her primary care physician.A similar dressing was re-applied; steri-strips and tape.The next day the mother purchased over the counter 3m¿ tegaderm¿ +pad film dressing from a local store.The mother performed daily dressing changes.Within approximately four days the child's skin started to get inflamed where the adhesive was in contact of her chin, then spreading to where the center of the dressing was in contact with the skin.After additional follow up with their clinician, an antibiotic and antihistamine were prescribed.The mother reported the initial cut is healing and the skin is red and flaky.No further information.

• Brand Name: 3M¿ TEGADERM¿
• Common Device Name: 3M(TM) TEGADERM(TM) +PAD FILM DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN
• Manufacturer (Section G): 3M HEALTH CARE; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; 6514612670
• MDR Report Key: 17431370
• Report Number: 2110898-2023-00067
• Device Sequence Number: 17612710
• Product Code: NAC
• UDI-Device Identifier: 04001895928345
• UDI-Public: 04001895928345
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/05/2026
• Device Model Number: 3584
• Device Lot Number: 33N56L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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: Other
• Patient Sex: Female