MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM SYNERGY; PROTECTOR, OSTOMY

Model Number	411658
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that moldable hole was off centered prior to use for six wafers from two market unit boxes with same lot.As a result, the end user felt a pinching sensation to her stoma and noted an indent on the stoma.The end user stated that there was no stomal trauma or laceration, no bleeding, and no medical intervention requested.She confirmed the stoma size was thirty-two millimeter (mm).The product was used by patient.No photograph or additional information was available at this time.
Additional Manufacturer Narrative
Device 6 of 6.E1: name of affiliation: (b)(4).Based on the available information, this event is deemed to be a reportable malfunction.Photograph, video and/or physical sample evaluation: no photograph associated with this case was received.No return sample has been received for this complaint.Batch record revision results: lot 4k02636 was manufactured on 10/oct/2024, in ats #1 line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 14/jul/2025, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material identification (id) (b)(4) and manufacturing order (b)(4).Review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue was found within the documentation.Historical complaints review: on 14/jul/2025, complaints investigator ran a query in database in order to verify the complaints reported for the 4k02636 lot for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ defect and no additional complaints were identified.Historical nonconformance review: on 14/jul/2025, the complaint investigator ran a query in database looking for any in process nonconformance / corrective and preventive actions (capa) (s) associated to the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ for the lot number 4k02636 and as result, no nonconformance / corrective and preventive actions (capa) (s) for this malfunction were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction (pi), the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: dimensional inspection: -film release liner: the film must remain intact along the length of the wafer without any cuts in the center hole.The film release tab must be free and not be trapped under the adhesive disk.¿ frequency: hourly ¿ sample quantity: (b)(4) samples per cavity ¿acceptance criteria: accept = 0 | reject = (b)(4) - collar concentricity: support ring concentric within 2.0 mm to the collar through the cut.¿ frequency: hourly ¿ sample quantity: (b)(4) samples of disc collar machine ¿acceptance criteria: accept = 0 | reject = (b)(4) - adhesive disc alignment: the disc must not contact the srp adhesive disc id collar and must be concentric within 2.0mm.¿ frequency: hourly ¿ sample quantity: (b)(4) samples per cavity ¿acceptance criteria: accept = 0 | reject = (b)(4) defect rate analysis: there have been only (b)(4) defective parts confirmed to date from a lot size of (b)(4) products.This represents a defect rate of only (b)(4) which is well within an appropriate acceptable quality level (aql) for leakage, which should be (b)(4) based on our standard operating procedure (sop).In addition, all the in-process testing on this lot did not find a single defective unit, which confirms that the lot is unlikely to breach an acceptable quality level (aql) of (b)(4).Importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: a review of batch records was completed and showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancies related to this issue were found within the documentation.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: ESTEEM SYNERGY
• 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 27409 ; 3365424679
• MDR Report Key: 22563281
• Report Number: 9618003-2025-02210
• Device Sequence Number: 9229089
• Product Code: EXE
• UDI-Device Identifier: 00768455186983
• UDI-Public: 00768455186983
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 411658
• Device Lot Number: 4K02636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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 Age: 55 YR
• Patient Sex: Female