MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problems Unspecified Infection (1930); Skin Irritation (2076); Tissue Damage (2104); Skin Inflammation (2443)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.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

End user reported she was hospitalized on (b)(6) 2019 for staph scalded skin syndrome.She states she was seen by an infectious disease physician who ¿suggested she may have an allergy related to the comfort panel¿ on the active life pouch.She stated the ¿she began using this specific type of pouch since her surgery on (b)(6) 2018.She did not have any issues prior to this event.Her normal pouch wear time is 2 to 3 days and she states she never has stool leakage.¿ the end user notes that she makes her own homemade soaps without any moisturizers to cleanse her skin.She stated ¿this began about twenty-one (21) days ago.The skin on her abdomen, where the comfort panel touches her abdomen is where it started.The skin started out as very red, hot, itchy and hard.¿ she was placed on oral antibiotics (name unknown).The area began to worsen and she developed large fluid filled water blisters that would fill up then pop on her abdomen.On (b)(6) 2019, she was admitted to the hospital due to the blistering and placed on intravenous vancomycin.She states ¿the skin blistered several times and the area filled with yellow slough material.¿ she does not know the size of the area but, states it is ¿anywhere below on the abdomen where the comfort panel touches her skin¿.End user called on (b)(6) 2019, informing she was out of the hospital, and on oral antibiotics (zyvox) and a topical antifungal (nystatin) with steroid in it.She reported her abdomen is now peeling and dark purple with no open areas and she is currently wearing a competitor¿s product.

Manufacturer Narrative

Corrected date of the event from (b)(6) 2019 to (b)(6) 2019.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

To date no additional patient or event details has been received.

• Brand Name: ACTIVELIFE
• Type of Device: POUCH, COLOSTOMY
• 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: 8700697
• MDR Text Key: 148050621
• Report Number: 9618003-2019-04377
• Device Sequence Number: 1
• Product Code: EZQ
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 86