The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.A review of the device history record is in-progress.All information reasonably known as of 28-jan-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
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The device history record for the reported lot number, 20035667, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.Photographs of the device was provided.The photographs were reviewed and showed that a reaction was observed in the customer's skin.Based on the use review, potentially, patient believes that it's from the local that hit his skin after he removed.A root cause was not identified.All information reasonably known as of (b)(6) 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by (b)(6) represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to (b)(6).(b)(6) has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a (b)(6) product is defective or caused serious injury.
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