MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I. V. SECUREMENT DRESSING; TEGADERM¿ CHG DRESSING

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, weight, ethnicity & race: information not provided.The lot # associated with this case has not been confirmed.The hospital reported three suspected lots: 334l9m, 334ccl or 334cw9.Initial reporter's full name, address, phone # and occupation not provided.The sample was not returned for evaluation.3m will continue to monitor.
Event or Problem Description
A facility in (b)(6) reported a (b)(6)-year-old female with an ij cvc line for antibiotic delivery developed skin lesions (denudation and maceration) with use of a 1657r 3m¿ tegaderm¿ chg chlorhexidine gluconate i.V.Securement dressing.The dressing was on for more than 24 hours.Multiple dressings had been applied.Prior to dressing applications, chloroprep/chg and cavilon¿ no sting barrier film were used.The lesions, presented under the chg gel pad, were noticed by hospital staff after cleaning of the site.The patient had no prior history of skin conditions or sensitivity to adhesive.Tegaderm¿ chg was discontinued, catheter was removed, and a new line was placed.The skin reaction healed.

• Brand Name: 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I. V. SECUREMENT DRESSING
• Common Device Name: TEGADERM¿ CHG DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9485076
• Report Number: 2110898-2019-00151
• Device Sequence Number: 3999435
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K080620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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 Expiration Date: 06/09/2021
• Device Model Number: N/A
• Device Catalogue Number: 1657R
• Device Lot Number: 334L9M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/17/2019
• 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