MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Product name: actual ostomy product is unknown.The end user could only provide: ostomy wafer - ref number unknown, 510(k) number: exempt, product code: exe, common device name: protector, ostomy.This emdr is being submitted since bleeding from stoma occurred which required cauterization.It was unknown if end user was cutting wafer beyond the cutting range due to time lapse and limited few details provided.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.Fda registration number reporting site: (b)(4), manufacturing site: (b)(4).

Event Description

The consumer reported that she experienced bleeding with one company¿s cut-to-fit (ctf) durahesive (dh) wafer with 1 3/4" flange, which cut into her stoma near the base approximately three years ago from an unknown number of durahesive ctf wafers out of unknown number of boxes with an unknown lot number.She experienced lot of bleeding, but denied the bleeding filled the pouch.She felt that the wafer barrier wore off and the flange ring was the problem.She stated that she went to a wound center where it was cauterized and followed up every two to three weeks for a few months.She did not remember if the area was cauterized after the initial visit.She further reported that she was told by the wound center to avoid 1 ¾¿ inch flanges.She experienced minor bleeding with appliance changes subsequently at intervals shortly after that, but it would resolve independently.She would remove the wafer and apply a new one until changed to larger wafer.No further concerns were reported since that time.She denied use of blood thinners.She denied any leakage under the wafer or skin irritation.She completed a tele-health visit which was in november 2022 but did not report this issue at that time.Other product use included seal and ostomy paste.She trialed one tele-health recommended company¿s wafer without incident.Due to time lapse, only a few details were provided.No photo available is available at this time.

• 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: 16047282
• MDR Text Key: 306159282
• Report Number: 9618003-2022-05416
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67
• Patient Sex: Female