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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A PS-2 PRM MP SUTURE, NONABSORBABLE, SYNTHETIC

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ETHICON INC. ETHLN BLK 18IN 3-0 S/A PS-2 PRM MP SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Model Number 1669H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 01/09/2020
Event Type  Injury  
Manufacturer Narrative

Product complaint # (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: age, gender, weight, bmi at the time of index procedure on what tissue was the suture used? what was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? what were current symptoms following the index surgical procedure? onset date? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra-op? were cultures performed? results? other relevant patient history/concomitant medications. Lot # for the ethilon suture. Will product for the same product code/lot number be returned for evaluation? return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.

 
Event Description

It was reported that the patient underwent a carpal tunnel procedure on an unknown date and suture was used. The area around the incision was infected and the skin around the incision was red. The patient was treated with antibiotics. Additional information has been requested.

 
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Brand NameETHLN BLK 18IN 3-0 S/A PS-2 PRM MP
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9723200
MDR Text Key185942135
Report Number2210968-2020-01259
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1669H
Device Catalogue Number1669H
Device LOT NumberPJJ360
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/18/2020 Patient Sequence Number: 1
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