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 REULAR FORCE NITI ARCHWIRES .014 NATURAL LOWER 11100141144/5 manufactured by Highland Metals, Inc..
[19301801]
A customer in the usa returned a mislabeled package of niti orthodontic wires (refer report 2939494-2013-00001). During investigation into that incident retention samples of product packed during same period were checked. The sample for product (b)(4), lot 41760, was found to contain. 014" natural lower form orthodontic archwires, not the. 014" natural upper form archwire as stated on the label. The archwire is marked with an ink midline - the midline should be a black color used for upper archwires but in this case were red color for lower archwires. This is easily identifiable by the assistant and doctor.
Patient Sequence No: 1, Text Type: D, B5
[19319277]
Three customers in the usa known to have received (b)(4) lot 41760 ((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 | 2939494-2013-00004 |
| MDR Report Key | 3553368 |
| Report Source | 05 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-20 |
| Date of Event | 2013-12-09 |
| Date Mfgr Received | 2013-12-09 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 REULAR FORCE NITI ARCHWIRES |
| Generic Name | WIRE, ORTHODONTIC |
| Product Code | DZC |
| Date Received | 2013-12-20 |
| Model Number | .014 NATURAL LOWER |
| Catalog Number | 11100141144/5 |
| Lot Number | 41760 |
| Device Expiration Date | 2018-11-04 |
| 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 | 2013-12-20 |