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

Model Number 022758

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation 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.(b)(4).

Event Description

Hold for cm 2/10 the end user reported that approximately 2 weeks ago, he experienced bleeding from stoma from an area at the skin and stoma edge at 9:00 for which he went to the hospital and it was cauterized.Reportedly, he was unsure of the cause or if it was related to wafer 022758, but stated it was possible.He also stated that he was on blood thinner medications eliquis and clopidogrel.Furthermore, he had no bleeding but experienced resultant discomfort near site from stool on his skin.He also denied leakage under the wafer but stated that stool did get on my skin at the edge of the wafer.He also added 839005 along with his current wafer and it worked better.His usual wear time was 3 days.Earlier documented colostomy but today stated stoma is ileostomy, present since 1999.Proper size and fit of barrier opening were reviewed.He preferred clipped closure, sent with measuring guide 400598 and 839002.He was agreed to ctf (cut to fit) wafer for trial.Reportedly, the end user continued to use the product.No photo is available at this time.

Manufacturer Narrative

(b)(4).Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation 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.(b)(4).

Event Description

The end user reported that approximately 2 weeks ago, he experienced bleeding from stoma from an area at the skin and stoma edge at 9:00 for which he went to the hospital and it was cauterized.Reportedly, he was unsure of the cause or if it was related to wafer 022758, but stated it was possible.He also stated that he was on blood thinner medications eliquis and clopidogrel.Furthermore, he had no bleeding but experienced resultant discomfort near site from stool on his skin.He also denied leakage under the wafer but stated that stool did get on my skin at the edge of the wafer.He also added 839005 along with his current wafer and it worked better.His usual wear time was 3 days.Earlier documented colostomy but today stated stoma is ileostomy, present since 1999.Proper size and fit of barrier opening were reviewed.He preferred clipped closure, sent with measuring guide 400598 and 839002.He was agreed to ctf (cut to fit) wafer for trial.Reportedly, the end user continued to use the product.No photo is available at this time.

• 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: 12873567
• MDR Text Key: 286321667
• Report Number: 9618003-2021-02717
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 022758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 81
• Patient Sex: Male