The investigation is underway.The dermaclip device is classified with fda as a class 1 medical device, product code kgx, 510(k) exempt.Dermaclip large 3 clip hospital devices come in a box of 12 packages, three large clips per package.Seven dermaclip large clips from three separate packages were used on the patient so dermaclip us is filing three mdr reports, one for each package of three clips.This event concerns the release of the adhesive on skin closure devices on a c-section incision.Prior to application, the incision was closed with subdermal and sub-cuticular suturing.Only the final dermal layer was closed with the dermaclip devices.After discovery of the released adheasive, the dermal layer was closed with sutures.Based upon the opinion of our chief medical officer, the patient was not at risk of serious injury or death as a result of the release of the adhesive.Devices from packages stored under similar conditions, to the packages containing the devices that failed were tested against packages stored by the manufacturer under temperature controlled conditions.The conclusion of that testing was: "using a two-sample t-test, the means from peel adhesive doesn't differ significantly between the two groups.Confidence level 95% p-value 0.0501." adhesive testing was performed on august 28, 2019, which is part of the larger investigation that is still underway.Further discussions with the patient's obgyn and various people involved.Once dermaclip us has finished its investigation we will send a follow up report to this mdr.This event is related to report # 3011656357-2019-00001 and mfr.Report #3011656357-2019-00003.(b)(4).
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Three packages of dermaclip large hospital devices for a total of seven dermaclip devices, were applied as the skin closure for a c-section incision after precedent closure through subcuticlar suturing.Twenty-eight hours after the surgery, the patient showered.After showering, it was discovered that the adhesive attaching the dermaclip devices below the incision line uniformly released.Patient reported the incident to the nurse and the attending physician replaced the dermaclip devices with sutures.Since each package contains three dermaclips devices, dermaclip us is filing one report for each package of the three dermaclip devices.This report is identical to mfr.Report #3011656357-2019-00001 and mfr.Report #3011656357-2019-00003.
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