|
Catalog Number TVTRL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Cramp(s) /Muscle Spasm(s) (4521)
|
Event Date 08/25/2023 |
Event Type
Injury
|
Event Description
|
It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.On (b)(6) 2023, mild levator spasm was noted.Unspecified drug therapy was provided and the event was recovered/ resolved without sequelae as of (b)(6) 2023.The levator spasm was reported as possibly related to the study device and study procedure.Additional information has been requested.
|
|
Manufacturer Narrative
|
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.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.Please provide the patient's demographic information including gender, weight, bmi at the time of index procedure name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? other relevant patient history/concomitant medications? please describe any medical intervention given 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? surgeon¿s name? facility name? product code and lot number? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
|
|
Manufacturer Narrative
|
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
|
|
Manufacturer Narrative
|
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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: a3, a4, b7, d1, d4, e1, h4.Additional information was requested and the following response was received: please provide the patient's demographic information including gender, weight, bmi at the time of index procedure female, 78.2kg, 32.83.Name of index surgical procedure? sling operation for stress incontinence the diagnosis and indication for the index surgical procedure? stress incontinence were any concomitant procedures performed? yes ¿ hysterectomy, uterosacral ligament suspension, cystoscopy, anterior and posterior repair.Other relevant patient history/concomitant medications? no.Please describe any medical intervention given including medication name and results.Flexeril ¿ resolved.What is the physician¿s opinion as to the etiology of or contributing factors to this event? levator ani tenderness.What is the patient's current status? recovered/resolved.Product code and lot number? tvtrl - 3943708.
|
|
Search Alerts/Recalls
|
|
|