MAUDE Adverse Event Report: ETHICON INC. SURGICEL* HEMOST.ABS 1.25X5CM; HEMOSTATIC AGENT, ABSORBABLE

Catalog Number	1955
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Initial procedure date please explain where do you believe that the surgicel was anatomically placed? what ethicon product was used? do you know the product code or lot number ? have you seen a physician or surgeon about this issue? if yes, what did they say about your condition? if in your possession, please provide a copy of your operative report?.
Event or Problem Description
It was reported that a patient underwent a total knee replacement procedure on an unknown date and absorbable hemostat was used.One week later, the patient noticed a skin irritation.The irritation is limited to the border of the bandage.The patient was given a low level steroid cream which slightly reduced the itching.The whole site is still red.The patient has seen a physician and a dermatologist.Additional information has been requested.

• Common Device Name: HEMOSTATIC AGENT, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7858647
• Report Number: 2210968-2018-75735
• Device Sequence Number: 1338374
• Product Code: LMF
• UDI-Device Identifier: 10705031003064
• UDI-Public: 10705031003064
• Combination Product (Y/N): N
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 1955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/08/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention