MAUDE Adverse Event Report: CONVATEC INC L3C3950 - FLEXI-SEAL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 418000

Device Problem Off-Label Use (1494)

Patient Problem Ulcer (2274)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Device 1 of 1.Contact office address: (b)(6).Complainant state: (b)(6).Patient country: (b)(6).Dealer: (b)(6).No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Based on the available information, this event is deemed to be a reportable malfunction/serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported by the user facility to the product distributor that there was "bleeding from an ulcer in the rectum".Upon further questioning it was noted that the fms device was placed for "collecting diarrhea and protecting perineal minor wound from stool".A rectal exam was not performed prior to placement of the device.The patient was not on any blood thinning agents.The bleeding was noted "(b)(6) ( 1week after from fms insertion)", and the bleeding was noted to be "bright blood".A rectal ulcer was observed via anoscopy done after the bloody stool was observed.They were unable to confirm the quantity of blood loss, but it was noted that the patient received 12 units of blood between (b)(6) 2021 to (b)(6) 2021.According to the complainant the retention balloon was filled with 35 ml of fluid.

• Brand Name: L3C3950 - FLEXI-SEAL
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7900 triad center drive; suite 400; greensboro, NC ; 3365424681
• MDR Report Key: 11743877
• MDR Text Key: 263398314
• Report Number: 1049092-2021-00067
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K112342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 418000
• Device Catalogue Number: 418000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1