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

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

Patient Problems Inflammation (1932); Swelling (2091)

Event Date 09/01/2019

Event Type  Injury  

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.Additional information: the actual device batch number associated with this event is not known.The possible batch number was reported as follows: batch t6006 - unknown corresponding product code.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.What are the patient age, weight, bmi, past medical and surgical history? what tissue layer was the unknown suture used on during initial procedure? what was the date of the initial c-section procedure? please explain ¿healing is not ideal¿? what was the date of the patient treatment? what is the surgeon opinion as to contributing factors to the symptoms? can you identify the name/ product code for the lot number t6006 of suture used? do you have any samples for evaluation? what is the current condition of the patient?.

Event Description

It was reported that the patient underwent a cesarean section procedure on an unknown date and suture was used.Approximately three days after the procedure, the patient experienced swelling and inflammation at the incision site.The healing is not ideal.After diagnosis, the patient was given anti-allergic and anti-infective therapy immediately.No additional information was provided.The current status of the patient is unknown.Additional information has been requested.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.- AURANGABAD; 312379@b-15/1; m.i.d.c., 1 walu; aurangabad ; IN
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9540980
• MDR Text Key: 185792303
• Report Number: 2210968-2020-00018
• 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: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention