(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details and or the device are received at a later date a supplemental medwatch will be sent.Do you have any photos? procedure name? procedure date? what is product code and code and lot number? can you describe the cellulitis reaction? how did patient appear at the 1 week follow up? does the surgeon believe this was hypersensitivity reaction? what date did the reaction occur post op? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over the prineo mesh during application? 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? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi; gender patient pre-existing medical conditions (ie.Allergies, history of reactions) for female patients ask: was the patient exposed to similar products, such as artificial nails? was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? what is the most current patient status? 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.
|