MAUDE Adverse Event Report: EAKIN; PROTECTOR, OSTOMY

Model Number 839002

Device Problems Material Discolored (1170); Material Too Rigid or Stiff (1544)

Patient Problems Laceration(s) (1946); Skin Erosion (2075); Skin Irritation (2076); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

An end user reports that the eakin seals are harder, darker, and grittier than normal.She stated that she developed a laceration on the side wall of her stoma.She further states that she uses the eakin seal with the sur-fit natura durahesive wafer and rolls the opening of the wafer back so, the only product in contact with the stoma is the seal.The seal was in use for one day when she developed the laceration.She reports that the skin near the laceration is eroded, raw and red.The end user was seen by her physician who diagnosed her as having an infection and ordered and antibiotic.The end user went on to inform that she has stopped using the eakin seals temporarily and has been crusting the skin with stomahesive powder and sensi-care barrier wipes.Additional information was received from the end user informing that the bleeding slowed after putting pressure on the site.The bleeding stopped after five days of changing the appliance daily; using a different seal ring along with a hyrofera blue foam ostomy dressing, and an unknown ostomy powder and sealer.She reports that both the laceration and the raw skin are now resolving and that t the infection cleared with the course of antibiotics.

Manufacturer Narrative

The manufacturing records for this lot were reviewed by the supplier and no nonconformities or any other abnormalities were identified.The manufacturing records for lot # 1093577799 were reviewed and there were no issues observed with both individual ingredients and final product passing all quality control testing.Retained stock from lot # 1093577799 was examined and there was no degradation observed in the final product.A visual examination was performed.The retained sample has been stored in an uncontrolled environment (but in accordance with the instructions for use) since manufacture.Whilst cohesive does not have an expiry date, some evidence of deterioration when stored outside of the recommended storage conditions; namely in high humidity has been reported.Therefore, suspect storage in high humidity may be a contributing factor with this complaint.This issue will be monitored through the post market product monitoring review process.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Manufacturer Narrative

Mdr 1049092-2018-00015 submitted on march 05, 2018 is being updated to include product problem, which was inadvertently missed on the initial submission.No additional event detail information has been provided to date.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.

Manufacturer Narrative

Correcting information initially submitted in section d, on 03/05/2018 for mdr 1049092-2018-00015, that should have been documented in section f.Correction to a.1 patient identifier on mdr1049092-2018-00015 / supplemental report 01, submitted on 04/3/2018, updating (b)(6).Correction to a.1 patient identifier on mdr1049092-2018-00015 / supplemental report 02, submitted on 04/20/2018, updating (b)(6).F.2: mdr 1049092-2018-00015 / follow-up# 03.F.3: (b)(4).F.4: (b)(4).F.5: (b)(4).F.6: 16-feb-2018 f.7: mdr 1049092-2018-00015 / follow-up # 03.F.8: 26-mar-2019.F.9: unknown.F.10: patient codes: 2076 -skin irritation, 2104- tissue damage, 2075-skin erosion, 1946- laceration(s).Device codes: 1544-mateiral rigid or stiff, 1170-material discolored.F.11: yes, 05-mar-2018.F.12: other, consumer.F.13: yes, 16-mar-2018.F.14: convatec , 211 american avenue, greensboro nc 27409.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Third party manufacturing site: 9681410.

• Brand Name: EAKIN
• Type of Device: PROTECTOR, OSTOMY
• MDR Report Key: 7314131
• MDR Text Key: 101525125
• Report Number: 1049092-2018-00015
• 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
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2019
• Device Model Number: 839002
• Device Lot Number: 1093577799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR