MAUDE Adverse Event Report: ALLMED MEDICAL PRODUCTS CO., LTD. HENRY SCHEIN; BANDAGE ADHESIVE STRIP FABRIC LF 1" X 3"

Catalog Number	112-6133
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peeling (1999)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient reported directly that he had a small one-eighth inch wound and the bandaid was placed on it.Upon removal of the bandaid the wound got bigger as the glue was too strong peeling some of the skin from his hand.He has since applied a gauze.
Additional Manufacturer Narrative
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.

• Brand Name: HENRY SCHEIN
• Common Device Name: BANDAGE ADHESIVE STRIP FABRIC LF 1" X 3"
• Manufacturer (Section D): ALLMED MEDICAL PRODUCTS CO., LTD.; no. 99 jin shan road; majiadian town; zhijiang city, hubei 44320 0; CH 443200
• Manufacturer (Section G): ALLMED MEDICAL PRODUCTS CO., LTD.; no. 99 jin shan road; majiadian town; zhijiang city,, hubei 44320 0; CH 443200
• Manufacturer Contact: william bagnasco ; 2 fleetwood ct.; ronkonkoma, NY 11779 ; 6316563800
• MDR Report Key: 18997749
• Report Number: 2435946-2024-00001
• Device Sequence Number: 2894102
• Product Code: KGX
• UDI-Device Identifier: 00304040024027
• UDI-Public: 00304040024027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/AN/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 112-6133
• Device Lot Number: A34722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male