MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM TRANSPARENT FILM DRESSING; TEGADERM¿ DRESSING

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Itching Sensation (1943); Peeling (1999); Rash (2033)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot #, expiration date, manufacture date: a lot number was not provided.Without a lot number, expiration and manufacture dates could not be determined.Multiple studies are regularly conducted that have demonstrated appropriate device biocompatibility and safety performance criteria when the device is used appropriately on humans.In addition to ensuring biocompatibility and safety performance, 3m closely monitors its manufacturing, controlling the release and functional characteristics of these medical devices.Skin injury to adhesive products can also be attributed to improper application or removal of the product.This consumer reported he had a smaller size tegaderm dressing applied to his leg and no reaction/skin injury occurred in that location.
Event or Problem Description
A consumer reported a physician applied a 1629 tegaderm¿ transparent film dressing during his follow-up appointment.The dressing was reportedly applied to his back, over his spinal stimulator implant incision.The consumer reported he experienced itching and a rash 1.5 days following the dressing application.His wife reportedly removed the dressing and skin removal occurred in some areas near the lower portion of where the dressing had been applied.The consumer was seen by his physician and was treated with an rx for methylprednisolone (4mg) (oral dose pack).The consumer was also instructed to use an otc ointment described as a thick paste.The consumer reported the open areas were healing, but still tender.

• Brand Name: 3M TEGADERM TRANSPARENT FILM DRESSING
• Common Device Name: TEGADERM¿ DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8641151
• Report Number: 2110898-2019-00079
• Device Sequence Number: 11220526
• Product Code: NAD
• UDI-Device Identifier: 04001895928741
• UDI-Public: 04001895928741
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1629
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR