MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-08-22 for INTER-PHALANGEAL STERILE SURGICAL KIT 360-2245 manufactured by Osteomed.
[18922938]
On (b)(6) 2014, an expired lot of interphlex interphalangeal rod 4. 5mm, lot 1034168 was implanted into the patient. The discrepancy was identified by the operation room manager while reviewing the patient file on the morning of (b)(6) 2014. This lot was manufactured by osteomed may 2010, and shipped to the surgery facility on (b)(4) 2010. The expiration date for this lot, as printed on the package, is 2014-05.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027754-2014-00009 |
| MDR Report Key | 4036782 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-08-22 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-08-18 |
| Date Mfgr Received | 2014-08-19 |
| Device Manufacturer Date | 2010-05-25 |
| Date Added to Maude | 2014-08-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LATOIA PHILLIPS |
| Manufacturer Street | 3885 ARAPAHO ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774743 |
| Manufacturer G1 | OSTEOMED |
| Manufacturer Street | 3885 ARAPAHO ROAD |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTER-PHALANGEAL STERILE SURGICAL KIT |
| Generic Name | INTERPHLEX FLEXIBLE STABILITY RODS |
| Product Code | KWH |
| Date Received | 2014-08-22 |
| Model Number | 360-2245 |
| Catalog Number | 360-2245 |
| Lot Number | 1034168 |
| Device Expiration Date | 2014-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | 3885 ARAPAHO ROAD ADDISON TX 75001 US 75001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-08-22 |