Model Number CLR222 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Inflammation (1932); Skin Irritation (2076); Tissue Damage (2104); Not Applicable (3189)
|
Event Date 11/18/2019 |
Event Type
Injury
|
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.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.How was the wound reaction managed? how was the reaction treated (prescription steroids; antibiotics prescribed)? please describe how was the adhesive applied on the tape.What prep was used prior to, during or after prineo use? 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? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.
|
|
Event Description
|
It was reported that the patient underwent total knee replacement on (b)(6) 2019 and topical skin adhesive was used.Post-operatively, the patient experienced a skin reaction at the surgical site aligned with the topical skin adhesive.The patient was re-admitted to manage wound reaction and superficial site infection risk.The patient experienced mild blisters and inflammation.The topical skin adhesive was removed and patient received wound reaction management.The surgeon opined they do not believe the patient experienced a true topical skin adhesive reaction and much of the redness was pink prep left under the topical skin adhesive.Following immediate removal of the topical skin adhesive, the patient progress was reported as very well.Additional information has been requested.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).Date sent to the fda: 2/12/2020.Additional information was received that there no issues with this device in the patient event.Therefore, this medwatch report will be void.
|
|
Search Alerts/Recalls
|