MAUDE Adverse Event Report: CONVATEC INC. AQUACEL AG SURGICAL (SCD); DRESSING, WOUND, DRUG

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No patient harm was reported.It was further reported that the product is " most likely (b)(4)." this information could not be confirmed at the time of this report.Additional patient/event information has been requested but no information has been received to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

Complainant reported that the "dressing stuck to the incision site during dressing removal." complainant stated that dermabond was used at the incision site and the dressing was applied twenty-four (24) hours later.

Manufacturer Narrative

Additional information: no lot number or product evaluation sample was available for investigation.Therefore, a detailed investigation or batch review cannot be conducted.This complaint evaluation will be closed and will be monitored through our post market product monitoring review process.No further actions are needed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on february 12, 2016.(b)(4).

• Brand Name: AQUACEL AG SURGICAL (SCD)
• Type of Device: DRESSING, WOUND, DRUG
• 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: 5400098
• MDR Text Key: 37179018
• Report Number: 1049092-2016-00024
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• 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
• Patient Outcome(s): Required Intervention