NUVAGEN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-26 for NUVAGEN manufactured by Ruspak Corporation.

Event Text Entries

[98765930] This non-serious spontaneous medical device complaint report from a customer (us) was received by (b)(4) (distributor) on 29-dec-2017. This customer complaint was forwarded to (b)(4) pharmaceuticals (product holder) on 02-jan-2018. Information has been received from a consumer concerning a female patient of unspecified age who was using nuvagen collagen powder. The patient's medical history and concomitant medication information was not provided. From an unspecified date the patient was using nuvagen collagen powder (1 gm packet) for wound dressing. Lot number was 150506 and expiry date was may-2020. On (b)(6) 2017, as soon as the patient applied nuvagen collagen powder to her wound, it started to swell and turn red. Patient also stated that on the pain scale from 1 to 10 that her pain was a 10. The patient and the physician were not aware that patient had any allergy history to bovine based products. No alternate primary wound dressing was ordered by the physician for this patient. Cpn has initiated the process to retrieve the remaining collagen powder back from the patient. It was reported that the leftover collagen powder was received from the patient and it appears that patient used 3 1/2 grams of the powder. The outcome of the event was not reported. The causality for the event wound swelling, turning red and pain after application of collagen powder was not reported. Case comment: the events application site swelling, redness and pain are assessed as non-serious, possibly related to nuvagen collagen powder based on the plausible temporal relationship and are unlisted as per the carton label.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1000526113-2018-70003
• MDR Report Key: 7222140
• Date Received: 2018-01-26
• Date of Report: 2018-01-25
• Date of Event: 2017-12-28
• Date Mfgr Received: 2018-01-02
• Date Added to Maude: 2018-01-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 6911 BRYAN DAIRY ROAD SUITE # 210
• Manufacturer City: LARGO FL 33777
• Manufacturer Country: US
• Manufacturer Postal: 33777
• Manufacturer G1: 1.BELCHER PHARMACEUTICALS, LLC
• Manufacturer Street: 2.RUSPAK CORPORATION (MANUFACTURER)
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: NUVAGEN
• Generic Name: NUVAGEN
• Product Code: KOZ
• Date Received: 2018-01-26
• Lot Number: 150506
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RUSPAK CORPORATION
• Manufacturer Address: 5 MANHATTAN STREET, P.O BOX 29 LYONS.TEL:(315) 946-9777 14489 US 14489

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-01-26