MAUDE Adverse Event Report: AQUACEL EXTRA; DRESSING, WOUND, DRUG

Model Number	420677
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.Additional patient/event details have been requested but none have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
Event or Problem Description
The end user reported that each package opened too easily and there were intermittent open areas along the seal.The dressings were not used.No photographs of the reported issue were provided.
Additional Manufacturer Narrative
A batch record review indicates no discrepancies.Fifteen (15) minute peel back checks within the controlled environment during the manufacturing of the batch were completed and all were satisfactory.During the manufacture of this batch all samples taken from the batch for sterile product inspection passed the burst test as well seal width measurements and visual inspection.Preventive manintenance logs have been checked and preventive maintenance was completed.No photos or samples were received in relation to 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).

• Brand Name: AQUACEL EXTRA
• Common Device Name: DRESSING, WOUND, DRUG
• MDR Report Key: 7088217
• Report Number: 1000317571-2017-00065
• Device Sequence Number: 13704229
• Product Code: FRO
• UDI-Device Identifier: 00768455127436
• UDI-Public: 768455127436
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K121275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Model Number: 420677
• Device Catalogue Number: 420677
• Device Lot Number: 7G03157
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR