(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided mhrauk.Primevigilance did reach out to obtain more information with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.
|
It was reported that the patient got cut by glass shards that came through the foam pad of the applicator.Chloraprep stick was activated prior to cleaning skin for a blood test.Noted blood stain on cotton pad of chloraprep stick and very small abrasion to patients skin.Questioning whether a shard of glass from the internal mechanism had passed through the cotton pad onto the patient's skin.Details of injury (to patient, carer or healthcare professional): small abrasion to skin of left anticubital fossa.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier).Mechanism of using a chloraprep stick explained to patient.Skin inspected for signs of glass - none found and no active bleeding.
|