MAUDE Adverse Event Report: COLOPLAST A/S MIO 1P LIGHT URO MX TRP10-23; COLLECTOR, OSTOMY

Model Number 1683501400

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

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

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, the patient was using 16837 since (b)(6) 2017.The hospital switched them to 16835 in (b)(6) 2019.The patient stated that ever since jan 1st.The skin became raw and an infection on the stoma occurred.A lot number was not available.The patient has been in the hospital since friday (b)(6) 2019.Stoma was black and green.The hospital is giving her antibiotics.They switched to 16837 and cut it in oval shape and it seems to be doing better.

Event Description

Was the patient hospitalized in (b)(6) 2019? if yes what was the reason for hospitalization? no.Hospitalized on (b)(6) 2019 for severe infection around her urostomy stoma.What was the reason for changing the product variant? stoma nurse suggested changing the size of the dome on the pouch.Did the patient previously have the same type of problems with the ostomy? (color / strangulation).No.Has the patient previously had mrsa infections? yes.In a port used for chemo infusion in (b)(6) 2017.Where was the mrsa infection diagnosed from the stoma? skin? sepsis? urine? mrsa diagnosed on (b)(6) 26 at hospital from swab of area around stoma.What kind of antibiotic treatment is the patient receiving? none now (b)(6) 2019, vancomycin & maxipime for four days in hospital.Amoxicillin at home for 14 days.Does the patient take any concomitant medication (steroid?) ? no.What is the reason for the patient having a urostomy? how long has the patient had the stoma? bladder removal due to cancer.Based on the available information it is medically assessed that: from the current available data it cannot be ruled out that the medical issue is related to the product.The end-user complaint of a mrsa infection which is expected to have led to discoloration of the stoma.(change in stoma colour to black/green (as described) may also be related to stoma strangulation/lack of blood supply) in order to know whether the infection is product related, coloplast is attempting to receive 3 samples from the same box/lot for further microbiological testing.The complaint should be classified as infection.

Event Description

Conclusion on medical assessment.Patient suffered from an infection requiring hospitalization (severity 3).Temporary damage/ no permanent damage.The actual root cause for the infection cannot be established.However, it seems unlikely that it is related to the product.Patient was changed from a product variant with a larger cut max to a variant with a smaller cut max, which seems to have initiated the initial changes to the peristomal skin and superficial infection.This may have influenced the onset/severity of the mrsa infection, but causality with the information available cannot be established.

• Brand Name: MIO 1P LIGHT URO MX TRP10-23
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, region hovedstaden 3050 ; DA 3050
• MDR Report Key: 8582989
• MDR Text Key: 144167709
• Report Number: 3003814961-2019-00001
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1683501400
• Device Catalogue Number: 1683501400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/22/2019; 06/21/2019
• Supplement Dates FDA Received: 06/19/2019; 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR