|
(b)(4).
The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
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.
Additional information was received from the affiliate stating: what is the procedure name: mammoplasty; what is the procedure date: (b)(6) 2016 (dd/mm/yyyy); how was the device was used (what layer of tissue and how many layers applied): applied in the epidermis; what was the location and incision size of prineo application: around 60cm; what prep was used prior to prineo application: it was performed hemostasis; was the prep allowed to dry prior to prineo mesh application: yes; please describe how the adhesive was applied on the tape: at first it was placed tape and after it was brushed; was the mesh placed over the entire length of the incision: yes; was the dermabond liquid adhesive placed to cover the entire length of the mesh: yes; did the prineo mesh extend beyond the patient incision: yes, around 2cm at the beginning and 2cm at the end; was incision re-prepped before closure, if so, with what, if so, was the prep allowed to dry: no; was the skin prep solution wiped off and let dry before applying adhesive: yes; was a dressing placed over the incision? if so, what type of cover dressing used: no; what date did the reaction occur on: (b)(6) 2016 (dd/mm/yyyy); what was done to address the reaction: bepantol ointment on site; what type of medication was used to treat the reaction: systemic corticosteroid predsim: what was the dosage: 20mg in 12/12h for 5 days; when (date) was the medication administered: (b)(6) 2016 (dd/mm/yyyy); was the product removed? was another method used to close the incision: no product withdrawal required; is the patient hypersensitive to pressure sensitive adhesives: the patient has no restrictions on the use of formaldehyde, she uses other products with the same substance without any problem; were any patch or sensitivity tests performed: no; what is the most current patient status: patient responded well after the observation and the bubble lowered; patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.
E.
Allergies, history of reactions) no history of reactions, (b)(6); was prineo previously used on the patient in a previous surgery, if yes what was the outcome of previous surgery: no, blister.
|
|
It was reported that the patient underwent mammoplasty procedure on (b)(6) 2016 and topical skin adhesive was applied in the epidermis.
The location and incision size was around 60 cm.
The mesh extended around 2 cm at the beginning and 2 cm at the end of the incision.
On (b)(6) 2016, the patient experienced an allergy with a blister, similar to a burning process, between the polyester tape and the application of the surgical glue.
It was reported that the patient does not have any restrictions on the use of formaldehyde and the patient uses other products with the same substance without any problems.
On (b)(6) 2016, the patient was administered bepantol ointment on the site and systemic corticosteroid predsim 20 mg in 12/12h for 5 days.
It was reported that the patient responded well after observation and the bubble lowered.
No additional information was provided.
|
|
(b)(6).
Additional information was requested and the following was obtained: what type of medication was used to treat the reaction.
Systemic corticosteroid predsim what was the dosage - 20mg in 12/12h for 5 days.
When was the medication administered - (b)(6) 2016.
Was the product removed.
Was another method used to close the incision.
No product withdrawal required.
Is the patient hypersensitive to pressure sensitive adhesives.
The patient has no restrictions on the use of formaldehyde, she uses other products with the same substance without any problem.
Were any patch or sensitivity tests performed - no.
What is the most current patient status - patient responded well after the observation and the bubble lowered.
Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.
E.
Allergies, history of reactions) no history of reactions with (b)(6) years old.
Was prineo previously used on the patient in a previous surgery - if yes what was the outcome of previous surgery - no.
|
