MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 2INX3IN(5.1CMX7.6CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 1953

Device Problem Material Integrity Problem (2978)

Patient Problems Inflammation (1932); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure due to an ankle fracture on (b)(6) 2023 and absorbable hemostat was used.During the surgery, a hemostatic gauze was placed in the wound to stop bleeding.On the fourth day after surgery, the patient developed redness, swelling, and oozing fluid at the wound.The doctor removed one needle and squeezed the wound, revealing a large amount of black and unabsorbed hemostatic gauze.Simultaneously, they carried out anti infection and dressing change treatment on the wound.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).H6.Component code: g07002 - device not returned to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: ¿ what is the procedure name? ankle fracture.¿ do you have any pictures of the reaction? no.¿ was there any other medical or surgical intervention performed (re-operation; re-closure with sutures; prescription medication)? if so, please specify.The doctor removed one stitch and squeezed the wound, a large amount of black absorbable hemostatic gauze that could not be absorbed was observed.The wound was also treated with anti-infection and dressing change.The following information was requested, but unavailable: ¿ please describe the anti infection and dressing change treatment on the wound, were sutures needed? unk.¿ if medication was required, please clarify if it was prescription strength.Unk.¿ what is the most current patient status? unk.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h 4.Device manufacture date, h 6.Type of investigation.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SURGICEL ORIGINAL 2INX3IN(5.1CMX7.6CM)
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17434275
• MDR Text Key: 320146452
• Report Number: 2210968-2023-05514
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003033
• UDI-Public: 10705031003033
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1953
• Device Lot Number: SEB6671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female