This report is based solely on the customer¿s allegation that resulted in a serious injury.Product manager (b)(6) of posey products was able to visit the customers facility and confirm no damages to the product and the unit functioned as designed.Customer confirmed patient was very agitated and in a combative state.The ifu states do not use this device on a patient who is or becomes: suicidal, highly aggressive or combative, self-destructive, or deemed to be an immediate risk to others, unless the patient is under constant supervision.At this time, there is no evidence that a manufacturing nonconformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.As a precaution, an internal investigation was initiated to investigate this issue further, assess risk, and determine next steps.Manufacturer reference file (b)(4).Product not returned.
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Tm reported via email incidents regarding the cuff.Newly purchased product in february 2021, 50 sets.No signs of defect or damage.Security officer was injured during an incident, limited details provided.Troubleshooting guide saved, no gtin.
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