MAUDE Adverse Event Report: ETHICON INC. SURGICEL SNOW ABS 2X4; HEMOSTATIC AGENT, ABSORBABLE

Catalog Number	2082
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fever (1858); No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Type of Reportable Event	Malfunction
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.Did the physician remove excess product after bleeding stopped? what is the physicians opinion on the factors contributing to the event? does the physician believe that there is any ethicon deficiency? initial procedure date? patient pre-existing conditions? patient demographics: id/ initials; age or dob; bmi?.
Event or Problem Description
It was reported that a patient underwent a breast mastectomy procedure on an unknown date absorbable hemostat device was used to control bleeding.Eight weeks, post op, the patient returned to the doctor, complaining of a low grade fever and raised swelling at the incision site.The doctor reoperated and found black pieces of the absorbable hemostat in the wound that had not reabsorbed.The doctor removed the product, irrigated and closed the wound.The patient was released and is fine.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Additional information was requested and the following was obtained: please cancel this product complaint.Surgeon does not believe this is due to our product.The device was not absorbed at 8 weeks post-op, however this was not the cause of the re-operation.

• Brand Name: SURGICEL SNOW ABS 2X4
• 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: 8388047
• Report Number: 2210968-2019-79238
• Device Sequence Number: 2051876
• Product Code: LMG
• UDI-Device Identifier: 10705031063594
• UDI-Public: 10705031063594
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 2082
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention