MAUDE Adverse Event Report: ETHICON INC. PDS+ U 70 CM M2 PS-8 PRIME; SUTURE ABSORBABLE

Catalog Number PDP516G

Device Problem Material Integrity Problem (2978)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.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.Note: events reported via 2210968-2022-05277.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.

Event Description

It was reported that a patient underwent an unknown orthopedic surgery (tumor : lower leg) on an unknown date in 2018 and suture was used to close the wound.From 2018 to 2022, inflammatory reaction has been confirmed in the sutured wound after surgery.When the patient takes steroids, it settles down, and when the patient stops taking steroids, the patient starts to have an inflammatory reaction.The patient requested re-operation in early july.The sutured wound will be cleaned and re-sutured.A reoperation using local anesthesia is scheduled to be performed in early (b)(6) 2022.Surgeon commented it is not known whether it is a problem with the patient's constitution or suture.Because inflammatory reaction appeared only in the sutured wound, the effect of the suture cannot be ruled out.Since it has been 4 years since the device was used, the surgeon did not think that the suture was hydrolyzed.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional information was requested, and the following was obtained: iplease provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure=>unknown.Date and name of index surgical procedure?=>2018.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)?=>it's the surgery for lower leg.On what tissue was each pds suture used?=>unknown.What was the tissue condition (normal, thin, calcified, fragile, diseased)?=>unknown.How was the suture placed (interrupted or continuous)?=>unknown.How was the suture originally tied (multiple knots, square knot, etc.)?=>unkwon.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation?=>unknown.Were there any pre-existing signs/symptoms of active inflammation prior to this surgical procedure?=>unknown other relevant patient history/concomitant medications?=>unknown please provide patient co-morbidities and medications in 2018?=>steroids.Please provide patient co-morbidities and medications currently (2022)?=>steroids.What symptoms did the patient experience following the index surgical procedure? onset date?=>since 2018, the inflammatory reaction has remained in the surgical wound until now.It calms down with steroids, occurs when stopped please describe any medical/surgical intervention required for this suture event including dates and results.=>steroids.What date is the patient scheduled for re-operation in early july 2022?=>unknown did the patient undergo reoperation yet? if yes, please provide details and findings.=>now checking.Were cultures performed? results?=>unknown were any pre-op cleansing procedures or products changed recently? if yes, please describe.=>unknown what is the physician¿s opinion as to the etiology of or contributing factors to this event?=>no further information is available.What is the patient's current status?=>unknown.Product code and lot number of each of the 2 sutures (pds 2-0, pds 3-0)?=>unknown any photos available?=>no photois available.The surgeon who perform initial procedure was unknown, so it is hard to get additional information about initial procedure.Now following the case.

• Brand Name: PDS+ U 70 CM M2 PS-8 PRIME
• 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: 14957724
• MDR Text Key: 295502231
• Report Number: 2210968-2022-05276
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PDP516G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2022
• 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