MAUDE Adverse Event Report: FLEXI-SEAL SIGNAL FMS RX ZEOLITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	418000
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed a serious injury.This complaint has been evaluated.No lot number is available.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional details have been requested but not provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).
Event or Problem Description
A wound care nurse reported that a patient who was already hospitalized (reason not provided) was treated with a flexi-seal because of diarrhea.The patient had stage 4 pressure ulcers (close to the bones) on the lower back after having been sitting up in a chair with a flexi-seal in place.A wound revision was performed (date not provided).It was reported that the wounds caused by flexi-seal extended the length of the hospitalization, but it was unknown for how long.The wound care nurse stated that ¿it is not the flexi-seal`s fault but because of wrong positioning.¿ although requested, no information was provided regarding how long the device was in use, the length of time the patient was positioned sitting up in a chair, or patient outcome.

• Brand Name: FLEXI-SEAL SIGNAL FMS RX ZEOLITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 6939129
• Report Number: 1049092-2017-00049
• Device Sequence Number: 1239458
• Product Code: KNT
• UDI-Device Identifier: 00768455117178
• UDI-Public: 768455117178
• Combination Product (Y/N): N
• PMA/510(K) Number: K112342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention