The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on (b)(6) 2022 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of (b)(6) 2022 unused returned product and unused retained product were submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.Refer to this report for further details.
|
On the initial report on (b)(6) 2022 consumer stated that the product caused a reaction/ injury.On completed cir received from consumer on (b)(6) 2022, he stated he applied the bandage in the morning before work to protect a small incision on his back.Consumer stated that around 5:30 pm, he rushed home due to an unbearable burning sensation on top of the incision and when the bandage was removed there was a blister on the exact size and shape of the bandage.Consumer added that the issue was with the whole bandage.He also stated had to seek medical attention due to the reaction and the pain that this caused and was prescribed steroids.Consumer also stated the symptoms corrected after stop using the product, but the pain and burning sensation stayed for days.
|