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Model Number 413521 |
Device Problems
Obstruction of Flow (2423); Material Protrusion/Extrusion (2979); Material Too Soft/Flexible (4007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Mdr 9618003-2023-00270 / device 1 of 4.(b)(6).Patient country: canada.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.
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Event Description
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The end user reported that moldable mass swelled and covered stoma after one day or less of wear time.She had initially experienced the issue with first four pouches from the box at home and she had been using this companys device successfully since (b)(6) 2022 and felt it was weird but could not find any solution to resolve the issue.Her stool consistently was like thick sauce, not liquid.She had put the first fresh bag on, within few hours of application, she felt heaviness and pulling effect, although bag was not full and didn't even eat a meal at that time.Then, she went to check and observed that material that hugged the stoma inside was swelled right up and covered her protruding one or half inch stoma, due to which she changed it immediately as she didn't know what to do.She is a single woman in her fifties, weigh around 110 (weight units unknown) with height 5'7" and she is on disability due to which she does not want to just change a bag in a careless way.Although her diet was even and she was taking loperamide for months and didn't have any issues with thickening agents the day before, she observed there was no stool because the stoma opening was covered, and she always used to look at window for proper connection of bag to the moldable center to make sure whether her stoma was placed right, but the event happened again and again.The day before she experienced an explosion in front of her family members, was never experienced by her before.She was quite happy with device with wear time of five days without any issues.But later on, when she wore the fourth pouch, she had to run to restroom all day to check since her stoma was right at the top of the swelling.Although stool could pass from stoma, but she changed before bedtime because of the risk of leakage.No photo was available at this time.
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Event Description
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To date no additional patient or event details have been received.
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Manufacturer Narrative
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(b)(4).In addition, bulk lot 2h0251001 sap material 1707112 manufactured in convatec moldable adhesive technology (cmt) line were reviewed and no issues found.Furthermore, bulk lots from in convatec moldable adhesive technology (cmt) (b)(4) and sap material (b)(4).Were manufactured in elc #7, batch were reviewed, and no problems related to the failure mode were found.On 02 jun 2023, a complaint search for lot 2h02719 and malfunction code - skin barrier migrates and obstructs stoma, was carried out and as a result, no additional complaints were found; therefore, no potential trend was observed and this case was considered an isolated incident.As per complaint manufacturing investigation procedure work instruction (wi), it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed and no potential trend was identified (therefore, considered an isolated incident).No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.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.
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Search Alerts/Recalls
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