MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,08 report with the FDA on 2010-04-05 for LARGE BONE, HALL BLADE, OSCILLATING 00507112900 manufactured by Conmed Linvatec.
[1648205]
Our (b)(4) distributor reported finding a defect in the package containing this sterile blade. There was no patient involvement, injury or surgical delay resulting from this event.
Patient Sequence No: 1, Text Type: D, B5
[8542150]
Investigation results: this blade and packaging was received for evaluation. A visual examination confirmed a hole in the package with potential breach in product sterility. The cause of this failure could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2010-00048 |
| MDR Report Key | 1656703 |
| Report Source | 00,01,08 |
| Date Received | 2010-04-05 |
| Date of Report | 2010-03-22 |
| Date of Event | 2009-12-11 |
| Date Mfgr Received | 2010-03-22 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2010-09-17 |
| 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 | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARGE BONE, HALL BLADE, OSCILLATING |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY |
| Product Code | KFK |
| Date Received | 2010-04-05 |
| Returned To Mfg | 2009-12-14 |
| Catalog Number | 00507112900 |
| Lot Number | 100134 |
| Device Expiration Date | 2014-10-11 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-05 |