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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problems Infusion or Flow Problem (2964); Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
A peritoneal dialysis (pd) patient reported that they had abrasions near their pd catheter and had to have surgery.The peritoneal dialysis registered nurse (porn) stated that the pd catheter surgery was for adhesion and omentum.The porn stated that the surgeon was unsure on how long this would work.The porn stated that they believe the patient in denial of what is occurring and that they are sure it is not a cycler problem.In additional follow-up, the porn confirmed the patient underwent pd catheter repositioning on (b)(6) 2020 due to omental wrapping and adhesions in the patient's abdomen.Per the porn, the patient was having pain and drain complications due to internal swelling from the pd catheter manipulation but has resolved since the patient's pd catheter site is healing.The patient reportedly continues pd therapy-on the same cycler without any harm or ill effect.The porn confirmed the patient did not have any adverse effects from use of any fresenius device, or product.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
PD CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17529080
MDR Text Key321104871
Report NumberMW5136009
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 12/14/2020
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
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