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

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Reaction (2414)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was unknown.The patient was seen in the clinic on (b)(6) 2018 and this date was used for the date of the event.Catalog and lot numbers were not known.Without a catalog and lot number, expiration date and manufacture date could not be determined.The cause of the reaction could not be determined.The reporter did not have a catalog, lot number or sample available for analysis.The patient also reportedly experienced a reaction to an adhesive closure device following a total knee replacement.An mdr was submitted for this adverse event because a rx topical ointment may have been applied for treatment of the reported reaction.End of report.

Event Description

A nurse from a dermatology clinic reported a patient experienced a scrape on her right medial ankle following removal of her compression socks.The nurse alleged a tegaderm¿ dressing was applied to the area.The patient reportedly experienced a reaction described as "black hemorrhagic skin and some erosion".The nurse reported the patient may have used rx lidex 0.5% ointment for treatment of the reaction.

• Brand Name: 3M TEGADERM DRESSING
• Type of Device: TEGADERM¿ DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 275 5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 7719555
• MDR Text Key: 115010975
• Report Number: 2110898-2018-00079
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2018

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 66 YR