MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-29 for COMFORTPRENE, BLUE 1/8 IN NC68002 manufactured by North Coast Medical, Inc..
[55996789]
This product is made of latex-free neoprene.
Patient Sequence No: 1, Text Type: N, H10
[55996790]
Per customer: "we at (b)(6) have started ordering your comfortprene as a replacement product for the neoprene we used to order through patterson medical that was discontinued. We made a hand splint for a young child, who had a reaction to the material after the first wear. It got progressively worse over time, after the splint was removed. The child was taken to the gp who said that it was a latex allergy and required medication to try to clear it up. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939821-2016-00001 |
| MDR Report Key | 5989091 |
| Date Received | 2016-09-29 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2016-06-22 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2016-09-29 |
| 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 Contact | MS. JENNIFER MOFFATT |
| Manufacturer Street | 8100 CAMINO ARROYO |
| Manufacturer City | GILROY CA 95020 |
| Manufacturer Country | US |
| Manufacturer Postal | 95020 |
| Manufacturer Phone | 4087765000 |
| Manufacturer G1 | NORTH COAST MEDICAL, INC. |
| Manufacturer Street | 8100 CAMINO ARROYO |
| Manufacturer City | GILROY CA 95020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMFORTPRENE, BLUE 1/8 IN |
| Generic Name | SPLINT COMPONENT |
| Product Code | ILH |
| Date Received | 2016-09-29 |
| Model Number | NC68002 |
| Catalog Number | NC68002 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | 8100 CAMINO ARROYO GILROY CA 95020 US 95020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-29 |