MAUDE Adverse Event Report: COVIDIEN BALLOON SLG 14 FR X 1.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	714170
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the patient experienced severe perigastrostomal granuloma, with continuous bleeding and local infection.The customer believes the top of the button is not ergonomic and states it enters with great difficulty.Consequences to the patient were: cauterization of granuloma, prolonged therapy, and need of frequent replacement.

• Brand Name: BALLOON SLG 14 FR X 1.7 CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11582985
• Report Number: 9612030-2021-02829
• Device Sequence Number: 4766935
• Product Code: KNT
• UDI-Device Identifier: 10884521010659
• UDI-Public: 10884521010659
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: No Information
• Device Model Number: 714170
• Device Catalogue Number: 714170
• Device Lot Number: 1727584964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other