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

Model Number	413184
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Ulcer (2274); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the consumer's wife who performs his ostomy care that the consumer had used this wafer for over a year.The appliance wear-time was two to three days.In (b)(6) 2021, consumer developed a small pimple just to the right of the stoma underneath the wafer mass.The wound enlarged to 25 x 38 mm with tunneling.Minimal, spotty bleeding occurred with appliance changes.No stool leakage was reported at that time.Consumer followed up with surgeon who ordered topical flonase and for consumer to follow up with dermatologist and local ostomy nurse.Surgeon made the diagnosis of ulcer and stated, these things sometimes happen and cause of wound was not suggested.No other diagnosis was made from dermatologist.Neither doctor of medicine (md) nor the ostomy nurse advised consumer to discontinue using convatec's appliance.Local ostomy nurse used alginate dressing from midway.The end user's wife stated that the wound was now 1/4 inch in diameter and there was no longer tunneling.She stated that the area was almost completely healed.The end user also uses an ostomy belt and reports that it was not worn too tightly and does not cause discomfort.Upon receipt of photos, the end user's wife was contacted to inform that the current wafer was too small for current stoma size in photo.She originally confirmed that current size was twenty eight mm.They were also going to follow up with surgeon regarding hernia.Photographs depicting the issue were received from the complainant.
Event or Problem Description
It was reported by the consumer's wife who performs his ostomy care that the consumer had used this wafer for over a year.The appliance wear-time was two to three days.In (b)(6) 2021, consumer developed a small pimple just to the right of the stoma underneath the wafer mass.The wound enlarged to 25 x 38 mm with tunneling.Minimal, spotty bleeding occurred with appliance changes.No stool leakage was reported at that time.Consumer followed up with surgeon who ordered topical flonase and for consumer to follow up with dermatologist and local ostomy nurse.Surgeon made the diagnosis of ulcer and stated, these things sometimes happen and cause of wound was not suggested.No other diagnosis was made from dermatologist.Neither doctor of medicine (md) nor the ostomy nurse advised consumer to discontinue using convatec's appliance.Local ostomy nurse used alginate dressing from midway.The end user's wife stated that the wound was now 1/4 inch in diameter and there was no longer tunneling.She stated that the area was almost completely healed.The end user also uses an ostomy belt and reports that it was not worn too tightly and does not cause discomfort.Upon receipt of photos, the end user's wife was contacted to inform that the current wafer was too small for current stoma size in photo.She originally confirmed that current size was twenty eight mm.They were also going to follow up with surgeon regarding hernia.Photographs depicting the issue were received from the complainant.

• 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: 13597712
• Report Number: 9618003-2022-00202
• Device Sequence Number: 5848226
• Product Code: EXE
• UDI-Device Identifier: 00768455124541
• UDI-Public: 00768455124541
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

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: 413184
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/25/2022
• 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 Sex: Male