MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-20 for SUPERELASTIC REGULAR FORCE NITI ARCHWIRES .016 NATURAL LOWER 11100161144 manufactured by Highland Metals, Inc..
[21661477]
A customer in the usa returned a package of niti orthodontic wires, product (b)(4), lot 41679 to highland metals inc. The customer indicated that the package contained. 016" natural upper form orthodontic archwires, not. 016" natural lower form archwire as stated on the label. The archwire is marked with an ink midline - the midline should be a red color for lower archwires but in this case were black color used for upper archwires. This is easily identifiable by the assistant and doctor. The wires had not been used by the doctor on any patient as it was noticed when the assistant unloading the archwires onto the tray for use by the doctor. The wire was received by highland metals inc on (b)(4) 2013 and it was confirmed to contain. 016" natural upper form niti archwires. The label was for. 016" natural lower form niti archwires.
Patient Sequence No: 1, Text Type: D, B5
[21914258]
Six customers in the usa known to have received (b)(4), lot 41679 ((b)(4)packs in total sent). These customers were sent a field safety notice on 2013-12-13 via fax or email informing them to check the product received to determine if it contains the wrong product. The doctor has been given the option to keep the product, or return to highland metals, inc for a refund. Distributors must contact each of their customers that may have received the product to inform them of the incident and for them to take the same action.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2939494-2013-00001 |
| MDR Report Key | 3553376 |
| Report Source | 05 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-20 |
| Date of Event | 2013-12-06 |
| Date Mfgr Received | 2013-12-06 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-01-07 |
| 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 | 0 |
| Manufacturer Contact | EVELINE CARR, ADMINISTRATOR |
| Manufacturer Street | 419 PERRYMONT AVE. |
| Manufacturer City | SAN JOSE CA 95125 |
| Manufacturer Country | US |
| Manufacturer Postal | 95125 |
| Manufacturer Phone | 4082712955 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERELASTIC REGULAR FORCE NITI ARCHWIRES |
| Generic Name | WIRE, ORTHODONTIC |
| Product Code | DZC |
| Date Received | 2013-12-20 |
| Returned To Mfg | 2013-12-06 |
| Model Number | .016 NATURAL LOWER |
| Catalog Number | 11100161144 |
| Lot Number | 41679 |
| Device Expiration Date | 2018-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HIGHLAND METALS, INC. |
| Manufacturer Address | SAN JOSE CA 95125 US 95125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-20 |