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

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

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994)

Event Date 11/05/2020

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.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.The patient demographic info: weight, bmi at the time of index procedure? please specify the suture product name/type/code? lot 20190201 is invalid, seems more as the date.Please provide a valid lot number? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please specify.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? how was the infection diagnosis confirmed? location and appearance of infection were cultures performed? results? please specify anti-infection medication was given and type (oral, topical or etc)? other relevant patient comorbidities/concomitant medications? was the wound re-sutured? if yes, when? what was used for re-suturing? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? were the symptoms of infection resolved.

Event Description

It was reported that the patient underwent perineal suture of a delivery surgery on (b)(6) 2020 and suture was used.The patient experienced fever and pain on the wound on or about the 30th post-operative day.Residual absorbable suture could be seen.It was reported that infection during the puerperium was considered and the doctor prescribed anti-infective therapy for the patient and removed the residual suture.Then the patient's condition changed to better.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.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10919189
• MDR Text Key: 219374984
• Report Number: 2210968-2020-09423
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/30/2020
• 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
• Patient Age: 25 YR