MAUDE Adverse Event Report: CONVATEC, INC ACTIVELIFE CONVEX ONE PIECE PRE CUT DRAINABLE

Model Number 175777

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

Patient Problems Bacterial Infection (1735); Erythema (1840); Itching Sensation (1943)

Event Type  Injury  

Event Description

The end user reported that approx four years ago, she developed peristomal redness with intermittent itching under the white tape collar.In 2013, she saw a dermatologist and was diagnosed with a bacterial infection to her peristomal skin.The end user was prescribed doxycycline to be taken for ten days.The end user alleged the redness did not improve while taking the antibiotic; however, the end user has not followed up with a physician since that time.No further info was reported.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.

Manufacturer Narrative

Additional information received november 17, 2015.The product associated with batch 4a00899 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous investigation, is applicable to this complaint investigation.This previous investigation is open.Therefore, this complaint will remain open until completion of the previous investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Previous non-conformance is applicable to this complaint and is closed.No further actions are required, and this complaint will be closed.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.No additional event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIFE CONVEX ONE PIECE PRE CUT DRAINABLE
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 4562213
• MDR Text Key: 19719449
• Report Number: 1049092-2015-00126
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2015

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/23/2019
• Device Model Number: 175777
• Device Lot Number: 4A00899
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2015; 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL; UNK PROTECTIVE BARRIER WIPE; UNK HYDROCOLLOID SKIN BARRIER STRIPS; ATENOLOL; MULTI VITAMIN; CALCIUM; FISH OIL; OMEPRAZOLE; SODIUM BICARBONATE; VITAMIN D; ZEASORB (OVER THE COUNTER); UNK TRANSPORE TAPE; MAGNESIUM; AMLODIPINE
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 76