MAUDE Adverse Event Report: CONVATEC , INC. SUR-FIT NATURA DRAINABLE POUCH, 12" OPAQUE

Model Number 401503

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

Patient Problems Itching Sensation (1943); Rash (2033); Reaction (2414)

Event Type  Injury  

Event Description

It was reported the end user developed itching and redness under the comfort panel of the drainable pouch, but continued to wear the pouch.After three days of wear, the end user replaced the pouch.Within an hour of wear, the itching under the comfort panel became progressively worse.He developed a rash that spread centrifugally from under comfort panel up to his extremities.The end user presented to the emergency room, where he was diagnosed with allergy to the comfort panel.He was issued a tapering prescription of prednisone for five days.The rash resolved within three days.The end user was also instructed to remove the comfort panel from the pouch prior to use.No further patient complications were reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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.Previous investigation is applicable to this complaint investigation.The previous investigation was closed.Therefore, this complaint will be closed without further action.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: SUR-FIT NATURA DRAINABLE POUCH, 12" OPAQUE
• Manufacturer (Section D): CONVATEC , INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal 3, haina ; DR
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 4917778
• MDR Text Key: 19607556
• Report Number: 9618003-2015-00035
• 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
• Report Date: 06/29/2015

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: 02/03/2020
• Device Model Number: 401503
• Device Lot Number: 5B00262
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 68