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

Model Number	404593
Medical Device Problem Codes	Fluid/Blood Leak (1250); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that four wafers from one market unit (mu) had off-centered starter holes.Two were used and two were not used.The end user reported that the off-centered holes on the wafers were out-of-box failures.He tried to use two but experienced leakage because of the defect.He decided not to use the other two with off-centered starter holes.No photo is available at this time.
Additional Manufacturer Narrative
Device 4 of 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 4f05643 was manufactured on 27/jun/2024, in convex 2 piece (pc) line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 12/mar/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) 1156501 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 12/mar/2025, complaint investigator ran a query in database in order to verify the complaints reported for 4f05643 lot for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ and as result no additional complaints were identified during this search as per work instruction (wi).Historical nonconformance review: on 12/mar/2025, complaint investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ for the lot number 4f05643 and as result, no nonconformance / capa (s) for this malfunction were generated during the manufacturing process of the referenced lot.Current quality controls (qc): 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: adhesive to convex disc centering (visual): nlt 0.095" (2.4mm) from id of the adhesive center hole to id of the convex disc at any point.(qc tool 1289).Picture frame srp: nlt 0.504" (12.8mm), width of the srp left at any point on the picture frame.(qc tool 1342-1).Picture frame srp to convex disc centering: nlt 0.040" (1.0mm) from the outer diameter of thermoformed disc to collar srp kiss cut inner diameter.(qc tool 1344-1).Frequency: hourly.Sample quantity: 5 samples.Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 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 process instruction (pi).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 aql of (b)(4) this issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted aql level for this type of failure mode or defect.Conclusions: a review of batch record 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.Additionally, a review of historical complaints was performed, and no additional complaints were identified, and a review of historical non conformances showed no additional non conformances.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: 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 27409 ; 3365424679
• MDR Report Key: 21707324
• Report Number: 9618003-2025-01149
• Device Sequence Number: 14623300
• Product Code: EXE
• UDI-Device Identifier: 00768455126675
• UDI-Public: 00768455126675
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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: 404593
• Device Lot Number: 4F05643
• 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: 03/10/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• 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