MAUDE Adverse Event Report: AMD MEDICOM INC. AMD-RITMED LAPAROTOMY SPONGE

Model Number	1501-ROLL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is in progress.
Event or Problem Description
A product complaint was reported to amd medicom on 28-aug-2020 for amd-ritmed laparotomy sponge item code1501-roll lot# 81043-1.The laparotomy sponge is classified as a class 1 medical device under fda code gdy.The following information was initially reported "lint on overhead table cover and instruments.Lint on liver during procedure" the complaint received by amd medicom has been logged as a product quality complaint under (b)(4).
Additional Manufacturer Narrative
An investigation was conducted.A probable cause is attributed to the use of the device with the tweezers tip which is sharp with burrs and scraping the sponges which generated fibers.Personnel are retrained on the stages of the manufacturing process to ensure the production process stays under control.
Event or Problem Description
A product complaint was reported to amd medicom on 28-aug-2020 for amd-ritmed laparotomy sponge item code 1501-roll lot# 81043-1.The laparotomy sponge is classified as a class 1 medical device under fda code gdy.The following information was initially reported "lint on overhead table cover and instruments.Lint on liver during procedure" the complaint received by amd medicom has been logged as a product quality complaint under (b)(4).

• Brand Name: AMD-RITMED LAPAROTOMY SPONGE
• Common Device Name: LAPAROTOMY SPONGE
• Manufacturer (Section D): AMD MEDICOM INC.; 2555 chemin de l'aviation; pointe-claire, quebec, canada ; CA
• MDR Report Key: 10706696
• Report Number: 9611959-2020-00003
• Device Sequence Number: 19679433
• Product Code: GDY
• UDI-Device Identifier: 20686864045216
• UDI-Public: 20686864045216
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1501-ROLL
• Device Catalogue Number: 1501-ROLL
• Device Lot Number: 81043-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1