MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-07-17 for NEO LOOP NC15760 manufactured by North Coast Medical, Inc..
[17072892]
He called on 7/13/2007. He said, his wife had a reaction to a strap used on an afo ankle and foot orthotic. He said, the straps were replaced one month earlier, and two days later his wife had an irritation that he says required 6 days of hospitalization. At that time, he stated his wife contracted a staph infection (staphylococcus aureus bacteria). Husband states this resulted in a permanent scar. One month later, the strap was replaced and the afo orthotic was disinfected. (the dates were verified with finger lakes prosthetics and orthotics).
Patient Sequence No: 1, Text Type: D, B5
[17306429]
Unable to obtain information from hospital and clinic. Unused material from user to be returned to manufacturer for testing of staphylococcus aureus bacteria.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939821-2007-00002 |
| MDR Report Key | 883029 |
| Report Source | 04 |
| Date Received | 2007-07-18 |
| Date of Report | 2007-07-17 |
| Date of Event | 2007-06-07 |
| Date Facility Aware | 2007-07-10 |
| Date Added to Maude | 2007-12-04 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Street | 18305 SUTTER BLVD. |
| Manufacturer City | MORGAN HILL CA 95037 |
| Manufacturer Country | US |
| Manufacturer Postal | 95037 |
| Manufacturer Phone | 4087765000 |
| Manufacturer G1 | ADVANCE FABRICATION |
| Manufacturer Street | 605 TENANT AVE. UNIT K |
| Manufacturer City | MORGAN HILL CA 95037 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95037 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO LOOP |
| Generic Name | SPLINT STRAPPING |
| Product Code | FZF |
| Date Received | 2007-07-17 |
| Model Number | NC15760 |
| Catalog Number | NC15760 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 923401 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | MORGAN HILL CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2007-07-18 |