MAUDE Adverse Event Report: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING, WOUND, DRUG

Model Number	412011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Itching Sensation (1943); Skin Inflammation (2443)
Date of Event	06/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable serious injury.  no lot number is available.Although a photograph has been received, no evaluation will be conducted.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No additional information has been received.Should additional information become available, a follow up report will be submitted.(b)(4).
Event or Problem Description
It was reported that the product was placed on the end user's right hip following total hip replacement on (b)(6) 2017.The skin was healthy upon removal of the dressing on (b)(6) 2017.No additional dressing was ordered to be placed on the area.On the evening of (b)(6) 2017, the end user developed severe itching and the skin adjacent to her incision had become red and inflamed but without blistering or weeping.It became hot and itchy and spread over the entire dressing contact site and beyond.She notified her surgeon and was directed to go to the emergency department on (b)(6) 2017 in which she was admitted.Benadryl was administered intravenously and she had a needle biopsy of the right hip joint on (b)(6) 2017 to rule out infection.The biopsy results showed no growth.She was discharged with a diagnosis of cellulitis and an allergic reaction to the hydrocolloid border.She was prescribed oral keflex for seven days.She reports the redness has decreased with a little itching and says the skin feels bumpy, leathery and dry.Photos depicting the reported complaint issue were provided review.No further details have been provided.

• Brand Name: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
• Common Device Name: DRESSING, WOUND, DRUG
• MDR Report Key: 6676992
• Report Number: 1049092-2017-00036
• Device Sequence Number: 16658978
• Product Code: FRO
• UDI-Device Identifier: 00768455124299
• UDI-Public: 768455124299
• Combination Product (Y/N): N
• Initial Reporter State: CT
• PMA/510(K) Number: K091034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: 412011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Weight: 84