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

Model Number	409269
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Erythema (1840); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Batch record revision results: lot 4c04601 was manufactured 21/mar/2024, in ats #1 line, with a total of (b)(4) market units (mkus).The complaints investigator performed a batch record review on 15/nov/2024, 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) 1169248 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 were found within the documentation.Historical complaints review: on 15/nov/2024, complaints investigator ran a query in database in order to verify the complaints reported for the 4c04601 lot for the malfunction ¿skin barrier does not mold around stoma (e.G too stiff, too dry, tears /crumbles when molding) at point of application¿ defect and no additional complaint was identified.Historical nonconformance review: on 15/nov/2024, complaints investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) associated to the malfunction ¿skin barrier does not mold around stoma (e.G too stiff, too dry, tears /crumbles when molding) at point of application¿ defect for the lot number 4c04601 and as result, no nonconformance / corrective action / preventive actions (capa) for this malfunction were generated during the manufacturing process of the referenced lot.Defect rate analysis: there have only been 01 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 this defect which should be 0.25% based on our standard operating procedure (sop).In addition, all of 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 0.25.To date, it is well within our accepted acceptable quality level (aql) for this type of failure mode or defect.Conclusions: as no photographs or samples were available for this complaint issue, it was not possible to confirm the issue reported.A batch record review 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 discrepancy 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.
Event or Problem Description
The wife of end user reported that the mass was less pliable prior to use.The end user used the wafers and noted they did not mold to fit the stoma size and shape as precisely compared to previous wafers used.She stated as a result of the mass being less pliable, end user developed redness to the immediate peristomal skin.End user's wife, also stated the skin irritation was a result of leakage of the product.Usual wear time was three-four days.The end user used company's adhesive remover, water to cleanse skin, absorptive and protective powder, company's barrier wipe, and company's barrier strips.He did connects to night drainage.Wife reported that she first noted this approximately one month ago.No photograph is available at this time.

• 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: 20861579
• Report Number: 9618003-2024-04158
• Device Sequence Number: 21049018
• Product Code: EXE
• UDI-Device Identifier: 00768455185702
• UDI-Public: 00768455185702
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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: 409269
• Device Lot Number: 4C04601
• 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: 11/12/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2024
• 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 Sex: Male