MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC UNKNOWN; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Type  malfunction  

Manufacturer Narrative

This investigation is in progress.A follow up report will be sent.

Event Description

The following was received from the pharmaceutical manufacturer whose drugs were used in this case through a cook peg enteral feeding tube.¿patient's spouse/approved caller stating that the patient is on duopa, also stated that the patient has "green discharge" at the stoma site [stoma site infection].The caregiver reported there is pus coming out of the site [infection at stoma site].She reported there has been no treatment for the drainage.Reported patient pegj getting replaced." a section of the device did not remain in the patient's body.The patient experienced stomas site infection that was treated with replacement of the tube.No further adverse effects were reported.

Manufacturer Narrative

An emdr report was initially sent on 05 july 2022, based on the information that the patient experienced a stoma site infection.Information was received stating that the patient was seen by a medical professional and they did not diagnose the patient with infection.It is reasonable to conclude that the green discharge is not infection but external leakage of bodily fluid.At the time of the complaint, the patient denies any stoma site infection.Based on the this information, this incident no longer meets the reporting criteria of an fda mdr report.

Event Description

This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional information section for this justification.

• Brand Name: UNKNOWN
• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 14914852
• MDR Text Key: 295248046
• Report Number: 1037905-2022-00360
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK JEJUNAL TUBE.
• Patient Outcome(s): Required Intervention