MAUDE Adverse Event Report: CONVATEC LIMITED EAKIN COHESIVE® SEALS, SMALL 2",(48MM)(1X20PK); PROTECTOR, OSTOMY

Model Number 839002

Device Problem Difficult to Remove (1528)

Patient Problems Erythema (1840); Skin Irritation (2076); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Height: 70 inches.Based on the available information, this event is deemed to be a reportable malfunction.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this complaint will be closed.This issue will be monitored through our post market product monitoring review process.Additional information has been requested, but no details have been provided at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

Complaint reported that the end user has peristomal skin redness under the (b)(6) cohesive seal.He said he has difficulty removing the (b)(6) cohesive seal from 5:00-7:00 o'clock and as a result has redness where it was adhering so well.A scant amount of blood from this area was also noted when removing the (b)(6) cohesive seal.He tried applying marathon liquid skin protectant to his peristomal skin but he had difficulty removing it from his skin and as a result he experienced skin irritation from it so he stopped using it.The peristomal skin redness started with the hollister adapt barrier ring but has worsened with the (b)(6) cohesive seal.This bleeding resolves without intervention.No further details have been provided.

• Brand Name: EAKIN COHESIVE® SEALS, SMALL 2",(48MM)(1X20PK)
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrical park; deeside, flinshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6094431
• MDR Text Key: 59775539
• Report Number: 1000317571-2016-00093
• Device Sequence Number: 1
• Product Code: EXE
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 839002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: HOLLISTER ADAPT BARRIER RING #7805; MARATHON LIQUID SKIN PROTECTANT,; MELATONIN, SAFE N SIMPLE ADHESIVE REMOVER,; METOPROLOL, GABAPENTIN, HYDROCODONE,; NAPROXEN, DIAZEPAM, ASPIRIN,; STOMAHESIVE POWDER
• Patient Age: 31 YR
• Patient Weight: 64