MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; POUCH, COLOSTOMY

Model Number 420695

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Blister (4537)

Event Type  malfunction  

Event Description

The end user reported that, pouches seam edges were rough and caused her to develop water blisters.The blisters were intact.Rough edges were all the way around the pouch.She used pantyliners to protect the skin.The usual wear time was three times per week by preference, and the wear time was not affected.No photo was available at this time.

Manufacturer Narrative

A2: age at the time of event - 70 years 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 3g02437 was manufactured on 12/jul/2023, in hodp line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 30/jan/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) 1706132 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction (pi) and recorded.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 30/jan/2024, the complaint investigator ran a query in database in order to verify the complaints reported for 3g02437 lot for the malfunction ¿pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿ and as result no additional type 2 complaints were identified during this search as per work instruction (wi).Historical nonconformance review: on 30/jan/2024, the complaint investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction ¿pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿ for the lot number 3g02437 and as result, no nonconformance / 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: test methods (tm)- "pouch non-conformities" ¿ frequency: hourly ¿ sample quantity: 10 pouches ¿ acceptance criteria: accept = 0 | reject = 1 defect rate analysis: there have only been 5 defective parts confirmed to date from a lot size of (b)(4)products.This represents a defect rate of only 0.050% which is well within an appropriate acceptable quality level (aql) for leakage which should be 0.25% based on our standard operating procedure (sop)"quality inspection plan".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 0.25 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: no objective evidence was received such as a photo or sample, for this reason, we cannot conclude that the product does not meet specifications.The review of the batch record 3g02437 showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements, all applicable manufacturing and quality processes were followed, and no discrepancies or deviations were recorded.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction ¿pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿.No additional complaints were reported for lot affected related to the malfunction ¿pouch materials in contact with skin are too rough or sharp (includes tap, filter, filter cover label, invisiclose fasteners, pursing strips, tail clip/closure, drainage adaptors)¿.Based on this, no negative trend was identified.Based on preliminary investigation results, there is no objective evidence that other products from this lot are impacted.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.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
• Type of Device: POUCH, COLOSTOMY
• 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: 18639412
• MDR Text Key: 335530201
• Report Number: 9618003-2024-00222
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 420695
• Device Lot Number: 3G02437
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female