MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Hypersensitivity/Allergic reaction (1907); Pocket Erosion (2013); Impaired Healing (2378)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received as 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.

Event Description

It was reported that a patient underwent an anterior cervical surgery on (b)(6) 2023 and suture was used on the patient's wound.Three days later, anaphylaxis occurred and the wound healed poorly.The doctor treated the patient with anti allergic drugs.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 1/25/2023.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.The following information was requested but unavailable: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Product code and lot number? name/type of suture? date of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? please describe the patient manifestations of the reported anaphylaxis reaction (location, severity, appearance, systemic or local reaction).Please describe any medical intervention required to treat the patient condition including medication name and results.It was reported that three days after the procedure, anaphylaxis occurred.Please clarify if this date represents the event date or the procedure date.Were any pre-op cleansing procedures or products changed recently? if yes, please describe.Does the patient have a known allergic history to any medical devices, food and/or medication? was allergy testing performed? if so, please describe with results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? are there any photos available? --all information above is unknown.

Manufacturer Narrative

(b)(4).Date sent to the fda: 2/21/2023.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information: h6 health effect - clinical code additional information was requested, and the following was obtained: after contacting with the hospital, the actual year of surgery in this event was 2022, and the specific month and date of surgery were unknown.The name of surgery was anterior lumbar fusion, not the anterior cervical surgery, the original information reported by the hospital was not corrected.The specific events were as follows: after investigation, the patient, a 57-year-old female, underwent anterior lumbar fusion in 2022 (with specific operation month and date unknown).The operator used the polypropylene non-absorbable suture produced by our company(with specific product model unknown) and other brand non-absorbable suture (with specific product information unknown) for tissue suturing (with specific suture tissue layer unknown) in the way of interrupted suturing.The intraoperative suturing was smooth.Three days after the surgery, the patient had allergic reaction (the specific symptoms and signs were unknown), so the doctor gave the patient anti-allergic drug treatment (the specific medication name, dose, use cycle, patient outcome and other key information were unknown).About half a year after the surgery (the specific event occurred on an unknown date), the patient had suture extruded from the wound and poor wound healing (the specific clinical manifestations were unknown).The local hospital (not the hospital reported the in this event) removed the extruded suture.Other treatments were unknown.Then the patient's wound healed.No subsequent adverse events were reported.(b)(4).Corrected information: b3.Corrected b5 narrative: it was reported that a patient underwent an anterior lumbar fusion procedure in 2022 and suture was used on the patient's wound.Three days later, anaphylaxis occurred and the wound healed poorly.The doctor treated the patient with anti allergic drugs.Additional information was requested.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• 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: 16156975
• MDR Text Key: 307274851
• Report Number: 2210968-2023-00311
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female