MAUDE Adverse Event Report: CONVATEC INC. POSTOP KIT: NATURA DURAHESIVE MOLDABLE SKIN BARRIER; BAG, DRAINAGE, WITH ADHESIVE, OSTOMY

Model Number 416932

Device Problem Device Handling Problem (3265)

Patient Problems Skin Discoloration (2074); Tissue Damage (2104)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.A detailed investigation or batch review is not required at this time.If additional complaints occur with this batch and with the same malfunction code, these subsequent complaints shall be assessed against the batch criteria data.This issue will be monitored through the post market product monitoring review process.Additional patient/event details have been requested, but none have been provided to date.Should additional information become available a follow-up report will be submitted.

Event Description

Complaint reported by the end user that after wearing the device for 2-3 days she noticed purple discoloration encircling stoma circumferentially extending out about one-eighth of an inch.There are no openings in the skin, just discoloration.She states the only change in her routine is that she has a new caregiver who cuts the wafer instead of molding the opening.No further details have been provided.

Manufacturer Narrative

A batch record review indicated no discrepancies related to the product quality or this complaint.Process checks and quality checks were performed with acceptable results.However, a non-conformance (nc) was noted for the mix product lot# (5c03629/1002208).Further investigation found this to be related to a documentation issue which has been resolved.The product quality was not affected by the nc and has been closed.No further investigation is required.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: POSTOP KIT: NATURA DURAHESIVE MOLDABLE SKIN BARRIER
• Type of Device: BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6239051
• MDR Text Key: 64433600
• Report Number: 1049092-2017-10001
• Device Sequence Number: 1
• Product Code: FON
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/17/2020
• Device Model Number: 416932
• Device Lot Number: 5E01787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (BRANDS UNKNOWN); ATENOLOL, INSULIN, 2 OTHER MEDS FOR DM, PAIN MEDS
• Patient Age: 61 YR