MAUDE Adverse Event Report: UNOMEDICAL S.R.O. L3O0215 - NATURA+; POUCH, COLOSTOMY

Model Number 421681

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The reported event is considered as an insufficient information since history of ongoing bleeding was reported with no actual cause or diagnosis.Additionally, both "customer and health professional" are (report source) since the end user is nurse who reported the event.Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: (b)(4).

Event Description

It was reported by the consumer who was a nurse that she was very unhappy with the pouch replacement and a voicemail was also received from end user's husband.She had an ongoing history of stoma bleeding, not related to company¿s product.However, when she used pouch, the additional force required to couple the pouch to the wafer made her stoma to bleed more and sometimes lost a lot of blood.She did not quantify amount of blood loss, but she would receive an endoscopy with stoma cauterization due to ongoing bleeding.There was no reported diagnosis or cause of bleeding.It was also unknown if the customer was wearing a belt.The end user assured that her stoma size did not change and the wafer was also fitting appropriately and it was not cutting into her stoma and did not have any rough edges.She reported there was no visible tissue damage to stoma other than bleeding.She was unable to determine if bleeding caused hospitalization or if it was caused due to taking blood thinners.No photo is available at this time.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.A batch record review was conducted resulting in the following: colostomy bags were manufactured under ref code/sap material id 1718503 and manufacturing lot # 1d02266 was produced in april 2021 with lot amount (b)(4) pcs.The production process, in-process control, testing result, packaging of products was run according to the process instruction line two piece closed end pouches and recorded in instructions.During production of lot 1d02266, pouches were tested on weld strength, using - weld stress test - (inflate the pouch to 2.5 psi leakage test pressure up to 20 second until film starts to deform/stretch has been done: on beginning of order 2 pouches tested by operator, on beginning of every shift 2 pouch tested by operator - air inflation test: on beginning of order 2 pouches tested by operator, on beginning of every shift 2 pouch tested by operator, during in-process control 1 pouch from every shipper (outer box) tested by operator.During weld strength testing were pouches connected on base plate with wafer.No connection issue was observed.Investigation conclusion.Review of the dhr showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.The process parameters were adjusted within the validated window.No nonconformity has been registered during the manufacturing process of the affected lot and of the mentioned issue.Also, several other similar complaints related to connection components are unable or difficult (requiring excessive force) to attach¿ were received on mentioned lot 1d02266.During production of product icc: 421681, lot 1d02266, were used all the right components.Flange bagside s2s 45mm modified, sap 1137320, various lots had been used during the production.Supplier of used incoming material sap 1137320 is knudsen plast.No nonconformity on raw material has been registered during the manufacturing process of lot 1d02266.Certificate of conformity and certificate of analysis were controlled.Material was released based on review of certificate.Based on negative trend of complaint issue was crb input solved on ad hoc crb meeting held on 20th of may 2021.The investigation associated with related rci has been approved and is complete at 01st of june 2022.Summary of the root cause and solution: following a forced conversion from legacy product to aps product, the coupling force required to attach the pouch and wafer was significantly increased.Some legacy customers failed to successfully attach the pouch to the wafer, resulting in complaints for non-use or leakage.Solution: -proposed ifu update coupling instructions to reflect a new step guide including a 4-point initial coupling, followed by overall coupling.-update training approach on ifu to ensure that step guides on 4-point initial coupling is communicated to end user.Corporate corrective/preventative action (capa) will be opened this investigation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092; manufacturing site: 3005778470.

• Brand Name: L3O0215 - NATURA+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14247610
• MDR Text Key: 290453111
• Report Number: 3005778470-2022-00025
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421681
• Device Lot Number: 1D02266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female