MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA CLASSIC SYSTEM REGULAR

Model Number 69003

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

Patient Problem Bowel Perforation (2668)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

The product was not available to be returned.Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.

Event Description

A female patient has been using the navina classic rectal irrigation system with regular balloon catheter.On (b)(6) 2022, the patient contacted her nurse and claimed that it is not possible to bring the rectal catheter up because it feels as if something is in the way, and she feels the need to take care of her stomach.The nurse aska female patient has been using the navina classic rectal irrigation system with regular balloon catheter.On (b)(6) 2022, the patient contacted her nurse and claimed that it is not possible to bring the rectal catheter up because it feels as if something is in the way, and she feels the need to take care of her stomach.The nurse asked her to gently feel as she usually does with a finger and then feel a fecal lump.Next, she brings up a new navina rectal catheter, on the side of the fecal mass, she then brings it up between the fecal mass and the intestinal wall, it seems, and then perforates the intestine.She called the nurse again and says she's bleeding and has very severe abdominal pain.The nurse advised her to go to the er with emergency rapid ambulance transport.After the incident the patient woke up with a stoma.Currently the patient feeling good after the last discussion with her nurse and doesn't want to be without her stoma.Ed her to gently feel as she usually does with a finger and then feel a fecal lump.Next, she brings up a new navina rectal catheter, on the side of the fecal mass, she then brings it up between the fecal mass and the intestinal wall, it seems, and then perforates the intestine.She called the nurse again and says she's bleeding and has very severe abdominal pain.The nurse advised her to go to the er with emergency rapid ambulance transport.After the incident the patient woke up with a stoma.Currently the patient feeling good after the last discussion with her nurse and doesn't want to be without her stoma.

• Brand Name: NAVINA CLASSIC SYSTEM REGULAR
• Type of Device: NAVINA CLASSIC SYSTEM
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, molndal SE- 4 31 2; SW SE- 431 21
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; molndal, molndal SE-43 1 21; SW SE-431 21
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o.box 14; molndal, molndal SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 16002282
• MDR Text Key: 305684403
• Report Number: 3009632672-2022-00006
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K190977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 69003
• Device Catalogue Number: 69003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Race: White