MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; PROTECTOR, OSTOMY

Model Number	413185
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Erythema (1840); Hemorrhage/Blood Loss/Bleeding (1888); Ulcer (2274); Tissue Breakdown (2681); Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is considered misuse.Per the ifu, convex wafers are contraindicated in patients with a hernia.The end user was recommended to discontinue use of convex wafer and transition to a flat wafer to aid in healing.Instruction and recommendation were provided to consumer on transitioning to a non-convex wafer to avoid ongoing pressure.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.(b)(4).
Event or Problem Description
This emdr is being submitted for an unknown number of wafers from unknown number of boxes.The consumer reported development of a peristomal ulcer about five weeks ago.The consumer who originally called company to find the alternative to another company's wound dressing to order for a treatment plan derived by a local wound center which he had scheduled follow-ups now weekly for a peristomal ulcer.Upon investigation, he stated the open area developed all of a sudden with the top layer of skin removed about five weeks ago.He reported it was located next to the stoma beneath wafer on the right lower side about the seven o'clock position and was about the size of a quarter and one-fourth inch in depth.He reported the tissue was red with some drainage.He also reported that he had been seen by a local wound care center for several weeks and they were treating it with gentamycin ointment 0.1 % cream, company¿s dressing and hydrocolloid cover every three days with appliance change.The consumer shared that he has been using convex precut wafer for many years and had never experienced this previously.He reported an average appliance wear time of five-seven days prior to ulceration and currently is changing every three days.He stated the use of a standard ostomy belt and had not used a hernia support belt for several years as it was too tight.The end user reported that he was prescribed an antibiotics of clindamycin 300 mg every six hours for ten days (forty capsules) last week and he had three days remaining and next wound clinic visit was scheduled for 8th of july, 2022.He further shared the use of convexity since origination for colostomy in 2015 due to enhanced seal with minimal stoma protrusion.The end user reported that he continued to see wound center and ostomy nurse and the peristomal ulcer was improving slowly but was cauterized at scheduled visit date due to some bleeding.He shared that ostomy nurse did not want him to change into a flat wafer at this time due to risk of leakage and possible contamination of wound.He reported that they did not seem to think the convexity was the issue but had not identified the cause.He stated ostomy nurse said he could try them after the ulcer heals but now is not ideal time due to risk of leakage and infection.The consumer continues follow up care at local wound center weekly.The customer was requested for photo submission of historical and current images.No photo is available at this time.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Batch record review results: the lot: 1l03201 was manufactured on 11/27/2021, convex 2 pc manufacturing line, with a total of (b)(4) market units.Complaint investigator id: (b)(4) performed a batch record review on 08/12/2022 to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct.Sap material 1161274 and manufacturing order: (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.On 08/12/2022 a complaint search for lot: 1l03201 and malfunction code: ost-pmc22.07 clinical misindication, enduser is using improper device for their medical condition and/or known risk factors was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed.As per complaint manufacturing investigation procedure wi-0359, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed and no potential trend is identified.Per phri, this complaint has been submitted to escalation for misuse, since the end user is using a convex product and is having hernia.Based on escalation meeting held on 12 jul 2022 - committee assigned ost-pmc22.07 clinical misindication, enduser is using improper device for their medical condition and/or known risk factors; based on additional information received, end user received cauterization.Committee assigned hc13.03 tissue damage, penetrating wounds, full thickness (i.E.Through the epidermis and dermis or mucosa); caused from trauma that reaches down to the underlying tissue; may require hospitalization and/or surgical intervention, severity 4; ost-pmc22.07 clinical misindication, enduser is using improper device for their medical condition and/or known risk factors 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: 9618003.

• Brand Name: L3O0200 - NATURA
• Common Device Name: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15137529
• Report Number: 9618003-2022-04587
• Device Sequence Number: 20267822
• Product Code: EXE
• UDI-Device Identifier: 00768455124558
• UDI-Public: 00768455124558
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 413185
• Device Lot Number: 1L03201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 08/14/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male