Model Number T-60 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Skin Irritation (2076)
|
Event Date 08/03/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Retained samples of the same lot number were inspected visually and mechanically.In addition, two electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.No further incidents have been reported to u.S involving the complained lot number.No conclusions as to the cause of the skin reactions can be drawn.Device not returned.
|
|
Event Description
|
On (b)(6) 2017, we have been informed by (b)(6), about an incident involving an unknown ecg holter monitor and skintact t-60 ecg electrodes.A holter procedure of 48 hours was performed.The patient's body type was described as slim and the skin type as "normal".In her medical history copd and a latex allergy were listed.The skin was cleaned with skin prep (model smith & nephew skin prep) and dried.Five electrodes were applied in the chest area.The skin has not been disinfected and not been shaven.The electrodes adhered properly.When the patient removed the electrodes after the procedure, abrasions and redness were detected underneath the gel and the adhesive area of at least 4 of the applied electrodes.The size of the injuries was characterized as "quarter size spots".It was reported that no treatment was necessary for the injuries, "just monitoring site for increased redness + signs of infection".
|
|
Manufacturer Narrative
|
Retained samples of the same lot number were inspected visually and mechanicaly.In addition, two electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.We received an already opened pouch with 11 electrodes for further investigation.The returned customer electrodes were visually investigated and revealed that they were totally dried out.The blue coloring of the sponge confirms the that the sponge had contained gel.No further testing could be performed on these returned samples because of the state they were in.No further incidents have been reported to us involving the complained lot number.No conclusions as to the cause of the skin reactions can be drawn.
|
|
Event Description
|
On (b)(6) 2017, we have been informed by (b)(6), about an incident involving an unknown ecg holter monitor and skintact t-60 ecg electrodes.A holter procedure of 48 hours was performed.The patient's body type was described as slim and the skin type as "normal".In her medical history copd and a latex allergy were listed.The skin was cleaned with skin prep (model smith & nephew skin prep) and dried.5 electrodes were applied in the chest area.The skin has not been disinfected and not been shaven.The electrodes adhered properly.When the patient removed the electrodes after the procedure, abrasions and redness were detected underneath the gel and the adhesive area of at least 4 of the applied electrodes.The size of the injuries was characterized as "quarter size spots".It was reported that no treatment was necessary for the injuries, "just monitoring site for increased redness + signs of infection".
|
|
Search Alerts/Recalls
|