MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used.After using on a cutaneous laceration for hemostasis, the health care professional observed that it was not absorbed in 1-2 weeks.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

(b)(4) 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.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 event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If this event occurred in multiple procedures, please provide the following information for each patient event: what is the procedure name? what is the procedure date? how was it concluded the product had not been absorbed? were there any patient consequences? did the patient report any signs or symptoms? if yes, please specify.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.If medication was required, please clarify if it was prescription strength.Can you identify the product code and lot number of the product that was used? what is the most current patient status? is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? if yes, to who and where can a return kit be send for recollection? 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 ABSORBABLE HEMOSTAT UNKNOWN
• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15125895
• MDR Text Key: 302522164
• Report Number: 2210968-2022-06045
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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