MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; PROTECTOR, OSTOMY

Model Number	125277
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Dizziness (2194)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is considered misuse.Per the ifu, a pre-cut ostomy device should not be cut.Correction - contact office address: (b)(4).Based on the available information, this event is deemed to be a reportable malfunction.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: (b)(4).
Event or Problem Description
The end user reported that he experienced bleeding where the stoma met the skin.He stated that it filled his pouch to one-third full of blood but unable to state if it was bright red or not.He went to the emergency because he became dizzy.His usual wear time was two to three days and did not change.He further stated that the health professional cauterized it at the emergency.He cleaned his skin with warm water and also cut the precut starter hole to oval shape for his stoma shape.He discontinued the use of company product and went back to using product of another brand.After using switching to another product the issue resolved.No photo is available at this time.

• Brand Name: L3O0200 - NATURA
• Common Device Name: PROTECTOR, OSTOMY
• 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: 13041879
• Report Number: 9618003-2021-02765
• Device Sequence Number: 13916889
• Product Code: EXE
• UDI-Device Identifier: 00768455125241
• UDI-Public: 00768455125241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 125277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 85
• Patient Sex: Male