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Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 requested, and the following was obtained:
allergy medication was prescribed, and the inflammation is showing signs of improvement.Physician's comment: the patient had a metal allergy, so titanium plates were used on both sides.The only difference between this surgery and the previous one is the use of this product, so i believe there is a causal relationship with this product.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.1.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure?
2.What were the diagnosis and indication for the index surgical procedure?
3.Please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.4.Was there any intraoperative concurrent use of other products?
5.What is the lot number?
6.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically?
7.Where was the surgicel used (on what tissue)?
8.How much surgicel was used during the procedure?
9.Was the surgicel product left in place? was the excess irrigated and removed?
10.What were current symptoms following the index surgical procedure? what was the onset date of the rash?
11.Has any surgical or medical intervention been performed?
12.If medication was required, please clarify if it was prescription strength.13.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative rash?
14.What is the patient¿s current status?
15.What is the users experience w/surgicel powder and other hemostatic agents?
16.Was a pneumatic tourniquet used during the procedure? if yes was it released prior to using the product.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, or its employees that the report constitutes an admission that the product, ethicon, 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.
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