Patient # 2 the product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.All information reasonably known as of (b)(6) 2023 has been included in this medical device report.O&m halyard, inc.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 o&m halyard, inc.Complaint database and identified as complaint#: (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
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Patient # 2.The sample was evaluated under ambient light conditions.The sample arrived inside a torn plastic product package.The plastic package was opened, and the sample was removed for inspection.The sample appears intact.The foam straps are wrapped as in the original state.The foam straps were carefully unwrapped.The foam straps appear intact.The sample does not exhibit any discoloration on the foam straps or on the foam pad.There are no sharp edges or damages observed on the wrist support.There are no damaged areas observed on the sample.The falure analysis lab is unable to evaluate the reaction experienced by the customer with the evaluation conducted in the lab.The manufacturer provided an investigation response indicating leaders, operators and the production coordinator were informed of complaint.The complaint lot production records were reviewed and inspection results were found to be within product specification.The manufacturer indicated no other complaints have been received within the prior 12 months.The manufacturer reviewed the injury photos and suggested that if the foam strip was tied too tight this may result in the observed pressure wound.Complaint has been logged in the o&m halyard, inc.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 an o&m halyard, inc.Product is defective or has caused serious injury.
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