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

Model Number	125266
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Abrasion (1689); Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681); Blister (4537)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is considered misuse.End user was cutting the barrier all the way to the flange which is contraindicative per the instructions for use (ifu).Based on the available information, this event is deemed to be a reportable malfunction and 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: (b)(4).
Event or Problem Description
The end user reported that she cut the barrier all the way to the flange but the product was still not large enough for her stoma.She described that it covered up part of the stoma and rubbed the stoma that caused blisters to bleed.She had a large parastomal hernia (larger than softball-sized) and also wears a hernia support belt.The ring on the belt also covered up part of the stoma and rubbed on the it.She also stated that she saw physician over a year ago for these concerns and the areas that she called blisters were cauterized but no diagnosis was provided.She also advised that a cream was recommended but the pharmacy didn't had it and she never got it.The end user reported that she was advised that larger products were available.Also based on information provided, she was advised that a one piece appliance would offer more flexibility and conformity to the abdomen and suggested two other company devices.She agreed to trial and samples were sent.The end user continued to use the product.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: 13391262
• Report Number: 9618003-2022-00074
• Device Sequence Number: 19807094
• Product Code: EXE
• UDI-Device Identifier: 00768455125456
• UDI-Public: 00768455125456
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/06/2022

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: 125266
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 01/31/2022
• 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: Female