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

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

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Pocket Erosion (2013); Fluid Discharge (2686)

Event Date 10/25/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent vaginal delivery on (b)(6) 2022 and experienced a perineal tear of 1 degree after surgery.The doctor used suture to sew the perineum.At discharge, the patient complained of foreign body sensation in the perineum.After discharge, on the 7th day after surgery, the patient checked herself and found that the secretion at the perineal suture had a peculiar smell.After coming to the hospital for inspection, the patient found that the intestinal suture was exposed, there was a small amount of purulent secretion, and there was a crack at the end of the wound with inflammation.The doctor removed the suture, disinfected the perineum with iodophor, and issued a doctor's order: potassium permanganate solution was used as a plate twice a day, after one week, it was healed.Additional information was requested.

Manufacturer Narrative

Product complaint #: (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).Attempts have been made to retrieve the device.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.Is potassium permanganate solution a prescription? or can potassium permanganate solution be purchased over the counter by the patient? did the patient experience an infection? where cultures performed? results? did the wound dehis? what type of suture was used? product code and lot number? please provide the patient's weight, bmi at the time of index procedure.On what tissue was the suture used? it was reported that ¿the intestinal suture was exposed¿.Was suture used on the intestines? if yes, please describe the reason why.Is the ¿intestinal suture¿ the type of suture that was used? if yes, what is the suture.What was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were any pre-op cleansing procedures changed recently? if yes, please describe.Other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.

Manufacturer Narrative

Product complaint#: (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.Additional information was requested, and the following was obtained: is potassium permanganate solution a prescription? unk.Or can potassium permanganate solution be purchased over the counter by the patient? unk.Did the patient experience an infection? yes.Where cultures performed? results? unk.Did the wound dehis? yes.What type of suture was used? unk.Product code and lot number? unk.Please provide the patient's weight, bmi at the time of index procedure.Unk.On what tissue was the suture used? skin of perineum.It was reported that ¿the intestinal suture was exposed¿.Was suture used on the intestines? if yes, please describe the reason why.No.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unk.How was the suture placed (interrupted or continuous)? continuous.How was the suture originally tied (multiple knots, square knot, etc.)? unk.Please describe any medical/surgical intervention required for this suture event including dates and results.The perineum was disinfected with iodophor, and bath with potassium permanganate solution twice a day.The wound was healed after a week.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unk.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? unk.Were any pre-op cleansing procedures changed recently? if yes, please describe? unk.Other relevant patient history/concomitant medications? unk.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unk.What is the patient's current status? good.If applicable, will product be returned? if so, please provide the return date and tracking information.No.

• 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: 16035795
• MDR Text Key: 306014114
• Report Number: 2210968-2022-10583
• 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
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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: 12/23/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female