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

Model Number 413182

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

Patient Problems Bacterial Infection (1735); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Contact office address: (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's wife reported that about one month before this report ((b)(6) 2021), the end user developed an "abcess" to the immediate right of the stoma, which measured slightly larger than 25mm and was pink in color with a white dot, no drainage.His primary care provider moved him to emergency services and he was seen in the emergency room three times.He had been seen past three mondays at the wound center where he had a scraping and was prescribed two different antibiotics.A biopsy was done on (b)(6) 2021 and the results are pending.He had taken two courses of the two antibiotics.He was given collagen powder to apply to the abcess but was not using it because it hurt when he applied the collagen powder.The end user's wife was unable to state the size of end user's stoma but stated that there was a small amount of skin showing between the stoma and the wafer stoma opening.The wafer "popped up" and "would not stay sealed" because it curved in and end user's abdomen curved out.His wear time was 1-3 days.The clinician at the wound center thought that the end user might benefit from a non-convex wafer.The end user continued to use the product.No photo is available at this time.

• Brand Name: L3O0200 - NATURA
• Type of Device: 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: 12531554
• MDR Text Key: 273290613
• Report Number: 9618003-2021-02465
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 413182
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• 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 Weight: 82