MAUDE Adverse Event Report: ETHICON INC. MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MONOCRYLUNK
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Itching Sensation (1943); Pocket Erosion (2013); Rash (2033); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional 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.Why does the surgeon feel that it is the suture that caused this reaction? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Name of index surgical procedure? the diagnosis and indication for the index surgical procedure? product code and lot number for the vicryl suture? product code and lot number for the monocryl suture? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was each suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was each suture placed (interrupted or continuous)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? how wound was closed? what dressing was used on the wound? it was stated that a few of the sutures had ¿popped and fell out," did the vicryl or monocryl suture break post-op? if yes, please specify which suture.It was stated that a few of the sutures had ¿popped and fell out." did the vicryl or monocryl suture extrude from the skin? if yes, please specify which suture.Please describe the patient manifestations of the reported reaction (location, severity, appearance, systemic or local reaction).Please provide the onset date/time of the reaction from the initial procedure.Was any specific intervention required for the difficulty breathing which was described as ¿having pressure on his lungs¿ with breathing? please describe any medical intervention required to treat the patient condition including medication name (other than the prednisone and benadryl) and results.Were any pre-op cleansing procedures or products changed recently? if yes, please describe.What surgical preparation was used prior to, during, or after product use? 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 patient have an infection? if yes, please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Please provide the onset date/time of infection from the initial surgical procedure.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.How much and what type of drainage is present in this wound? please describe any medical intervention performed including medication name and results.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? note: events reported in 2210968-2022-03242.
Event or Problem Description
It was reported that a pediatric patient underwent an unknown procedure on (b)(6) 2021 and suture was used.Following the procedure, the patient had itching and a rash.It was found to be systemic.The patient was seen by the doctor and then the rash became significantly worse following the appointment.The patient was taken to an urgent care center and was prescribed a prednisone burst and benadryl 50mg.The mother of patient was told by the provider at the urgent care center that it some sort of allergic reaction to the suture material.Mainly because of the appearance of the incision and the child having difficulty breathing which was described by the mother as not wheezing or sob, but he described it as ¿having pressure on his lungs¿ with breathing.The mother reported that the child subconsciously scratches his surgical site and his rash because it¿s so itchy, which could explain the swelling, redness, and potential for a very superficial infection/irritation on his incision.The mother also said that she is no longer able to visualize any sutures, a few of them had ¿popped¿ and fell out, but she¿s unsure if the incision is too swollen to see them or they¿re all out at this time.There is purulent drainage from that area.Additional information was requested.

• Brand Name: MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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
• MDR Report Key: 14279273
• Report Number: 2210968-2022-03246
• Device Sequence Number: 5198235
• Product Code: GAN
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MONOCRYLUNK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown