MAUDE Adverse Event Report: CONVATEC LIMITED DIAMONDS ODOR CTRL TR105 (1X100 JAR); BAG, DRAINAGE, WITH ADHESIVE, OSTOMY

Model Number 420791

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on october 19, 2016.(b)(4).Not returned to manufacturer.

Event Description

It was reported that an ostomized patient, who is a frequent user of the diamonds sachets, went to the medical service with diarrhea and a nurse opened the sachet and poured its contents into the patient's stoma.Per additional information received on october 10, 2016 bowel pumping was performed on the patient.Patient status is unknown.

Manufacturer Narrative

Upon further review of the reported event, it was determined that a detailed investigation or batch record review is not required.This investigation will be closed.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: DIAMONDS ODOR CTRL TR105 (1X100 JAR)
• Type of Device: BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: jeanette johnson ; director, quality complaint; handling unit, 7900 triad ctr; dr., ste 400 greensboro,, NC 27409 ; 3365424681
• MDR Report Key: 6041597
• MDR Text Key: 57877294
• Report Number: 1000317571-2016-00083
• Device Sequence Number: 1
• Product Code: FON
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 11/01/2017
• Device Model Number: 420791
• Device Lot Number: T02250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2013
• 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
• Patient Outcome(s): Required Intervention