MAUDE Adverse Event Report: AVERY DENNISON CORPORATION RELIATECT POST-OP DRESSING WITH CHG; DRESSING, WOUND, DRUG

Model Number	0496-0568-76
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Avery dennison received a complaint from the ob/gyn department of a hospital in (b)(6) through its distributor.The complaint indicated that skin redness was observed after use of the reliatect post-op dressing with chg on a patient that underwent a c-section surgical procedure.A follow-up communication from the hospital stated that the skin redness experienced by the patient was mild and was treated with a topical ointment.No additional treatment was required.Furthermore, no patient sensitivity was known prior to the use of the post-op dressing containing chg.Based on the nature of the incident, retain samples were tested for performance characteristics.All the results were found to be within device specifications and no device malfunction was identified.In addition, avery dennison conducted a device history record review of the reported lot.The review confirmed that the performance characteristics were within specification at the time of product release.  .
Event or Problem Description
Avery dennison received a complaint from the ob/gyn department of a hospital in florida through its distributor.The complaint indicated that skin redness was observed after use of the reliatect post-op dressing with chg on a patient that underwent a c-section surgical procedure.

• Brand Name: RELIATECT POST-OP DRESSING WITH CHG
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): AVERY DENNISON CORPORATION; 7100 lindsay dr., bldg. 14; mentor OH 44060
• MDR Report Key: 11164625
• Report Number: 3003764829-2021-00002
• Device Sequence Number: 17041191
• Product Code: FRO
• UDI-Device Identifier: 00817138010517
• UDI-Public: 00817138010517
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K163529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 07/15/2022
• Device Model Number: 0496-0568-76
• Device Catalogue Number: 0496-0568-76
• Device Lot Number: K0711A01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 01/13/2021
• 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: Other
• Patient Age: 30 YR