Product was not available for evaluation.Manufacturer evaluated the device history record and retain samples.- item 1126133 was adhesive bandage, packed as per (b)(6) pks/box, (b)(6) boxes/cs, (b)(6) pks/cs.- the production process is as follows: adhesive coating - incoming inspection - loading materials on machine (substrate, medical paper rolls, releasing paper, absorbent pad) - forming and cutting - cutting the bag units - peeling bag units into single piece, box/case packing - inspection and entering into warehouse.- the dhr of and retain sample of this complained batch was reviewed: - the production process was under control without abnormity, and no change on manufacturing technology, used materials, equipment, labor, production area and environment.- the start-up verification, in-process quality control and final quality control were inspected and qualified, and the mass products were released normally.- the retain sample of this complained batch was reviewed, the adhesive status was good, and the peeling strength was tested, and the value was within the peeling strength of product spec.Product id lot# peeling strength aver.Result 1 2 3 4 5 6 7 8.1126133 a34722 38.48 32.66 36.26 35.73 40.53 39.80 39.58 40.70 37.97 ok.- the used substrate was fabric: tbj-f01, the adhesive coating grammage was within specificaiton (55+10/-5g), and the materials were inspected and qualified before issued to related process.Substrate#: tbj-f01 lot# of substrate: e32d-22122853 lot# of adhesive: e235-22100206 grammage: 55.7g.- item 1126133 was launched in production since nov 2017, and we have produced (b)(4) batches with quantity of (b)(4) cs/(b)(4) pks.The customer complaint from 2017 till now was reviewed, this is the first complaint of "too strong" - there was no change on material suppliers, each material was inspected and qualified before entering warehouse or used in related process.The retain sample of customer complained batch was good and the glue status was normal, and the peeling strength was tested, and the value was within spec: the peeling strength of product shelf life, and no abnormity was found during ipqc.
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