[118878390]
This non-serious spontaneous medical device complaint report from a customer (us) was received by (b)(4) (distributor) on (b)(6) 2018. This customer complaint was forwarded to (b)(4) (product holder) on (b)(6) 2018. Information has been received from a consumer concerning a (b)(6)-year-old patient who was using nuvagen collagen powder. The patient's medical history and concomitant medication information was not provided. On an unspecified date the patient started to use nuvagen collagen powder (1 gm packet) for an unknown indication. Lot number was 170308a and expiry date was feb-2022. The patient reported using nuvagen collagen powder for three days and changed it daily. On (b)(6) 2018, during the initial application, the patient noted burning sensation. It was reported that the sensation worsened the longer it was on. Burning sensation was intense enough to prevent the patient from sleeping. No other side effects were noted. There was no report of rash or itching or hives or shortness of breath or tachycardia. The physician ordered vitamin e. Complaint sample was not available at the time of this report. (b)(4) initiated the process to retrieve the remaining collagen powder back from the patient. The outcome of the event was not reported. The causality for the event 'burning sensation' was not reported. Case comments: the event application site burning is assessed as non-serious and possibly related to nuvagen collagen powder based on the temporal relationship and spontaneous nature of the report. The event is unlisted as per the product label.
Patient Sequence No: 1, Text Type: D, B5