Retained samples of the concerned lot number stated in the initial report [lot number: 190821-0359] were inspected visually and tested mechanically.The mechanical tests were performed on 3 retained samples.We also received customer samples for further testing.These electrodes had also been inspected visually and tested mechanically.All tested electrodes were within limits, no failure could be detected.The involved device has not been made available for an investigation.The ifu states "to prevent skin injuries, take special care when removing the electrodes from sensitive skin (e.G.In the case of elderly patients, diabetics, patients under medication, such as steroids, which may have a skin weakening side effect)." the ifu also requires electrodes to be applied only by a mdical doctor or an adequately trained staff member.According to the questionnaire, the patient's skin was described as fragile.In addition, skin thinning is a known adverse effect of the medication the patient was reported to be on (prednisolone [cortisone]).It is unclear whether the medical staff was following the ifu.Based on the results of product tests and the information provided in the questionnaire we conclude that a user error might have caused or contributed to the incident.
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On october 24th, 2019, we have been informed about an incident with ecg electrodes at (b)(6).Skintact ecg electrodes (model fs-wb00) were used.The initial report stated "the adhesive on the electrode is extremely sticky - more than is usual, making them very difficult to remove.The injury today was from a further batch of electrodes." we have requested further information and received a filled in questionnaire.[in the filled in questionnaire it was stated that the concerned lot number is 190909-0359 with the expiration date 08/21/2019.Reviewing the produced electrode models and the corresponding lot numbers we assume that this injury belongs to the lot number specified in the initial report: 190821-0359]: a 5 minutes 12 lead ecg was performed.The patient was described as slim and the general status of the patient was described as normal.The skin type was described as normal.The medical history of the patient was as polymyalgia rheumatica with "prednisolone medication commenced on (b)(6) 2019".The skin was not cleaned, not shaven, not disinfection and no ointment had been used before applying the ecg electrode.10 electrodes were applied in total to the patient.The electrodes were placed on the patient's chest, forearm and legs.It was reported that the injuries were detected "immediately underneath the adhesive area" at the right and left forearm."patient removed the electrode from the left arm.Senior nurse removed the right arm electrode using saline".The injuries were described in size of about 2cm.A photo of an injury was provided.On the photo a scale was pictured.Based on the scale we are able to determine that the patient developed a longish skin tear of 10 x 1 mm.The injury was treated by "steristrip and dressing applied".
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