Catalog Number CLR602 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Inflammation (1932); Rash (2033)
|
Event Date 01/01/2021 |
Event Type
Injury
|
Event Description
|
It was reported a patient underwent a breast augmentation surgery on an unknown date and topical skin adhesive was used.Patient had rash around breast area approx.5 days after surgery.Surgeon treated area with diprosone cream and prednisolone steroids'.Additional information has been requested.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.Did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown.Did the patient require revision surgery or hardware removal? no.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? prednisolone and diprosone cream.Patient status/ outcome / consequences? patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? inflammation and redness with a rash.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown.Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is a photo available, please provide.Date of procedure? date of reaction? please describe how was the adhesive was applied.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions)? has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? current patient status.No product is available for return.
|
|
Event Description
|
It was reported a patient underwent a breast augmentation surgery on an unknown date and topical skin adhesive was used.Patient had rash around breast area approx.5 days after surgery.Surgeon treated area with diprosone cream and prednisolone steroids'.Additional information has been requested.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.Did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown.Did the patient require revision surgery or hardware removal? no.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? prednisolone and diprosone cream.Patient status/ outcome / consequences? patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? inflammation and redness with a rash.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown.Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is a photo available, please provide.Date of procedure? date of reaction? please describe how was the adhesive was applied.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi.Patient pre-existing medical conditions (ie.Allergies, history of reactions)? has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? current patient status.No product is available for return.
|
|
Search Alerts/Recalls
|
|