Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problem Constipation (3274)
Event Type  Injury  
Event Description
A peritoneal dialysis (pd) patient reported to fresenius technical services that they had a hernia.However, there was no specific allegation that the event was due to any malfunction or deficiency of any fresenius device(s) or product(s).Upon follow-up with the patient's pd registered nurse (porn), it was found the patient did not experience a hernia.The porn reported the patient underwent a planned, outpatient procedure for a hydrocele repair in (b)(6) 2020 (exact date unknown).It was reported the patient's hydrocele was attributed to complications of the patient's pd catheter (not a fresenius product) and abdominal straining due to constipation.The patient was not hospitalized following this procedure; they were transitioned to in-center hemodialysis (hd) which they performed through an existing fistula for three months to allow resolution of the hydrocele.Additionally, it was found the patient's pd catheter was in malposition and repositioned following-this outpatient procedure (exact date unknown).It was confirmed the patient's hydrocele and the pd catheter malposition were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient resumed pd therapy on the same liberty select cycler at home on (b)(6) 2020.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PD CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17536651
MDR Text Key321161501
Report NumberMW5143535
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
-
-