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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE SUTURE - NON-ABSORBABLE, SYNTHETIC, POLYAMIDE

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ETHICON INC. ETHILON NYLON SUTURE SUTURE - NON-ABSORBABLE, SYNTHETIC, POLYAMIDE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Inflammation (1932); Swelling (2091); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. The single complaint was reported with multiple events. There are no additional details regarding the additional events. 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. 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. Specific number of patients that had wound dehiscence relating to nylon suture? for each patient event please provide the following information: please provide specific product code and lot number involved. Please provide timelines of dates (initial procedure date, event date, reoperation date)? was there any evidence of suture breakage (nylon suture)? did the suture pull through the tissue? was the tissue condition compromised? what medical or surgical interventions were performed? how was the issue resolved? update to patient current condition. Patient demographics (initials, dob, bmi). Any product to return for analysis.

 
Event Description

It was reported that a patient underwent hip surgery on an unknown date and suture was used. The suture was possibly used on the skin and in the subcuticular layer. The patient possibly experienced dehiscence, swelling, discharge and inflammation. When the doctor cut the non-absorbable suture to open the wound he found a complete dehiscence of the deeper layers. Additional information has been requested.

 
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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Additional information was requested and the following was obtained: the only thing that we are 100% aware of is that since we have stopped using all j&j sutures all have problems have gone away. We have not had one more wound breakdown. There were photos given to the reps when they were here as well, and there you can see what happened to the wounds. The majority were taken to theatre between 1-3 weeks post op for secondary suturing and the same goes for the secondary suturing that were done here in the rooms. Once the secondary suturing was performed then the wounds healed within 10 days or so. The swabs that we did take on random patients all came back negative. The other answers that we could answer is on your email below in red. Please provide timelines of dates (initial procedure date, event date, reoperation date)? the patients started notifying the rooms of wound problems between 1 - 4 weeks and secondary suturing was done immediately. Was there any evidence of suture breakage (monocryl suture)? yes. Was there any evidence of suture breakage (vicryl suture)? yes. Did the suture pull through the tissue? yes. Was the tissue condition compromised? yes. What medical or surgical interventions were performed? secondary suturing how was the issue resolved? secondary suturing. Update to patient current condition. Patient demographics (initials, dob, bmi). Any product to return for analysis was never requested.

 
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Brand NameETHILON NYLON SUTURE
Type of DeviceSUTURE - NON-ABSORBABLE, SYNTHETIC, POLYAMIDE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7455732
MDR Text Key106383892
Report Number2210968-2018-72318
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeSA
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/24/2018 Patient Sequence Number: 1
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