MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE; POUCH, COLOSTOMY

Model Number 022771

Device Problem Sharp Edges (4013)

Patient Problems Laceration(s) (1946); Pain (1994); Discomfort (2330); Tissue Breakdown (2681)

Event Type  malfunction  

Manufacturer Narrative

Contact office address: (b)(4).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.(b)(4).

Event Description

The end user applied 1 out of box of 10 wafers and it caused pain to the stoma.She further stated that "when cutting wafer, some sharp edges were left, which cut a bit into her stoma" (possibly resulting in pain/discomfort).She was not cutting beyond the cutting guide.The sharp edges were after the wafer was cut.Reportedly, the pouch was not the correct size for her stoma.The end user continued to use the product.No photo available is available at this time.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.Correction (g1) - contact office address: (b)(4).No sample, video or photo was received for evaluation; for that reason, the malfunction reported by the customer could not be confirmed.Lot 9f02271 was manufactured on 06/20/2019 in the guard manufacturing line, with a total of (b)(6) market units.On 02/dec/2021, compliance engineer id 5173 performed a batch record review, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, under sap material 1003073, icc code 022771 and manufacturing order 1466086.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according the process instruction.On 02/dec/2021 a complaint search for lot 9f02271 and malfunction code was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed.As per complaint manufacturing investigation procedure, it is not required to open a nonconformance report (ncr) for complaints which were not confirmed (either by photo, video or sample provided by the customer, or as a result of the batch record review) and no potential trend is identified.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.Fda registration number reporting site: 1049092.Manufacturing site: 9618003.

Event Description

To date no additional patient or event details have been received.

• Brand Name: L3O0100 - ACTIVE LIFE
• 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: 12622471
• MDR Text Key: 281432459
• Report Number: 9618003-2021-02570
• 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,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 022771
• Device Lot Number: 9F02271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2019
• 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