MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE; BAG, URINARY, ILEOSTOMY

Model Number 650831

Device Problem Material Disintegration (1177)

Patient Problems Laceration(s) (1946); Tissue Damage (2104); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

The end user reported that in an unknown number of pouches from unknown number of market units with unknown lot numbers, the mass was disintegrating, exposing a thin, clear plastic film.He changed every 4 days.He stated that near the end of wearing it for the 4th day, he experienced bleeding that he attributed to this while on blood thinners.He reported a dark red laceration to the stoma on the right side of the stoma, approximately 1/4th inch in size.The end user believed that when the plastic was being exposed with the smaller wafer size, it was causing trauma when he had to make a sudden change is position.The end user was unable to give the date of occurrence for the injury.He stated that the first time was approximately 1 year ago when he sought medical attention as he went to the emergency department and had labs drawn.He was instructed to follow up with his urologist and he did.The urologist employed "wait and see" approach and the bleeding subsided after approximately 20 hours.He did not have the date of the emergency department visit or date of physician visit.He did not have the results of the labs.He was using 1-1/8" wafer with irregular shaped stoma and level of protrusion fluctuated at times.No photo is available at this time.

• Brand Name: ACTIVELIFE
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10807940
• MDR Text Key: 215298650
• Report Number: 9618003-2020-15115
• Device Sequence Number: 1
• Product Code: EXH
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 650831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• 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: 72