MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for NUVAGEN manufactured by Ruspak Corporation.
[93434900]
This initial non-serious spontaneous report, which originated from the united states, was received on 15-sep-2017. Information has been received from a consumer concerning a female patient on 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). Batch number and expiry date was not provided. On (b)(6) 2017, while applying nuvagen collagen powder, the subject experienced pain at wound site. It was reported that the patient had wounds between her toes and the wounds were severe. When the consumer applied collagen powder to her mother's wounds, the patient could not tolerate as she had pain at wound site. The patient received alginate with silver per order from doctor. Action taken with nuvagen collagen powder was not reported. Outcome of the event 'pain at wound site' was not reported. The reporter stated that due to the severity of the wounds, any dressing would have caused the pain at the wound site and that it was not actually related to the collagen powder itself. A product quality complaint was raised and complaint sample was not available. No further information was provided.
Patient Sequence No: 1, Text Type: N, H10
[93434901]
This initial non-serious spontaneous report, which originated from the united states, was received on 15-sep-2017. Information has been received from a consumer concerning a female patient on 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). Batch number and expiry date was not provided. On (b)(6) 2017, while applying nuvagen collagen powder, the subject experienced pain at wound site. It was reported that the patient had wounds between her toes and the wounds were severe. When the consumer applied collagen powder to her mother's wounds, the patient could not tolerate as she had pain at wound site. The patient received alginate with silver per order from doctor. Action taken with nuvagen collagen powder was not reported. Outcome of the event 'pain at wound site' was not reported. The reporter stated that due to the severity of the wounds, any dressing would have caused the pain at the wound site and that it was not actually related to the collagen powder itself. A product quality complaint was raised and complaint sample was not available. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000526113-2017-70002 |
| MDR Report Key | 7042070 |
| Date Received | 2017-11-17 |
| Date of Report | 2017-12-22 |
| Date of Event | 2017-09-14 |
| Report Date | 2017-10-20 |
| Date Reported to Mfgr | 2017-10-20 |
| Date Mfgr Received | 2017-10-20 |
| Date Added to Maude | 2017-11-17 |
| 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 (PRODUCT HOLDER) |
| Manufacturer Street | 2. RUSPAK CORPORATION (MANUFACTURER) |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUVAGEN |
| Generic Name | NUVAGEN |
| Product Code | KOZ |
| Date Received | 2017-11-17 |
| Lot Number | 150216, 150216A AND 150506 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RUSPAK CORPORATION |
| Manufacturer Address | 6911 BRYAN DAIRY ROAD 5 MANHATTAN STREET, P.O.BOX 29 LYONS. TEL: (315) 946-9777 NY 14489 US 14489 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-17 |