MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVE LIFE; BAG, URINARY, ILEOSTOMY

Model Number	650832
Medical Device Problem Code	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 end user reported that ten appliances from one market unit had starter hole off centered as the product was not cut to correct size all the way around the wafer.Also, the wafer body side appeared smaller than the non-body side.The device used to cut the wafer did not cut the wafer in correct way which made its opening too small.The end user stoma size was not changed because he was ordering a different precut product that was precut to the same size of thirty-two millimeter (mm), that did not have this appearance and fits him correctly.The product was not used by patient.The photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Mdr 9618003-2024-03504/initial 8 of 10.Based on the available information, this event is deemed to be a reportable malfunction.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.
Additional Manufacturer Narrative
Correction: h4: device manufacture date - in initial emdr, the manufacture date was added as 20 august 2024, but the batch record confirms the manufacture date is 03 june 2024.Hence, it has been corrected.Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: photograph, video and/or physical sample evaluation: ¿ there was a photograph associated with this case and in this, the reported defect can be seen.Batch record revision results: lot 4f00352 was manufactured on 03/jun/2024, in convex 1 pc line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 07/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) 1004090 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 07/nov/2024, complaint investigator ran a query in database in order to verify the complaints reported for 4f00352 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 type 2 complaints were identified during this search as per work instructions (wi).Historical nonconformance review: on 07/nov/2024, 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 (pre-cut only)¿ for the lot number 4f00352 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: - srp image frame (quality control tool # 1342).- convex disc centering adhesive (quality control tool # 1289).- fabric collar to disc concentricity (quality control tool # 1257).- molded dimple centering (quality control tool # 1315-small, # 1323-large).Frequency: hourly.Sample quantity: 2 samples (1 per station).Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 10 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 acceptable quality level (aql) of (b)(4) this issue certainly appears to be an isolated incident, but more 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 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 and manufacturing site: 9618003.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: ACTIVE LIFE
• Common Device Name: BAG, URINARY, ILEOSTOMY
• 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: 20209389
• Report Number: 9618003-2024-03504
• Device Sequence Number: 7202488
• Product Code: EXH
• UDI-Device Identifier: 00768455190263
• UDI-Public: 00768455190263
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 08/20/2024

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: 650832
• Device Lot Number: 4F00352
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: Unknown