MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN ANAL IRRIG SYSTEM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 2912101001

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

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast 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 the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, training of the patient at home in presence of nurse and sales representative.The patient inserted the catheter above the toilets.2 pumps of the balloon were done by the nurse.The sale representative heard the balloon inflating and asked the patient if the catheter was correctly inserted.He said yes.During the instillation, the water was flowing and the catheter fell off.There was faeces on catheter and on the patient's hands.The faeces was sticky.They tried again with a new catheter, the sales representative heard again the balloon inflating.The water was flowing and the catheter fell off again.There were still faeces on the catheter.The rectal ampulla seemed to be full and the sale representative stopped the tai.The patient felt no pain.The patient made enema during the evening on the nurse's recommendation.After the enema, the patient suffered acute abdominal pains, tremors and sweat.The patient was hospitalized in the night.Ct scan confirms the presence of air in intraperitoneal area.No visible lesions on the mucosa.Atb treatment.Favorable evolution of the patient condition.The patient discharged home.

• Brand Name: PERISTEEN ANAL IRRIG SYSTEM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY KFT; coloplast utca 2; szabolcs-szatmar-bereg; nyirbator, 4300 ; HU 4300
• Manufacturer Contact: mike bumgarner ; 1601 west river road n; minneapolis, MN 55411 ; 6122630488
• MDR Report Key: 9511097
• MDR Text Key: 173319471
• Report Number: 3006606901-2019-00021
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K112860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2912101001
• Device Catalogue Number: 2912101001
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other