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

Model Number 421643

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Impaired Healing (2378); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 reported that the wafer was too hard and caused wounds and pain to peristomal skin.He stated that the wounds developed about a month ago.One was tear drop shaped above stoma and the other was like a pencil eraser size below stoma.They were deep and bled through the dressings daily.The end user was unable to quantify the amount of blood lost but stated it was probably a couple of drops but it soaked through the dressings.Additionally, he reported that moving around and bending was causing the hard plastic to push into the wounds, not allowing them to heal.He wore a belt but wore it loose and not all the time.When wounds first started, his doctor prescribed an oral antibiotic for a week.The end user denied leakage and hernia/bulge to area.The nurse provided prisma dressing to put in wounds and cover with duoderm.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 ; 7900 triad center drive; suite 400; greensboro, NC ; 3365424681
• MDR Report Key: 11751253
• MDR Text Key: 248145406
• Report Number: 9618003-2021-00781
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 421643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2021
• 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 Age: 55