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 2007-11-30 for HALL LARGE BONE OSCILLATING BLADE 00507158200 manufactured by Conmed Linvatec.
[17472611]
It was reported by our distributor in japan that the 9800 package containing this sterile blade has a crack in the tray.
Patient Sequence No: 1, Text Type: D, B5
[17662454]
No medwatch form received from the user facility. Investigation results: the device was received for evaluation. A visual inspection found no damage to the outer box containing this product but found a crack/hole in the corner of the blister package which contains the blade. Further investigation found that the sterility of the product is compromised. A review of product history for the past 2 years found no other similar reports for this problem. There is one other reported problem for this lot number and blade packaged in the same box. This blade is sold sterile, in a box of 5.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00843 |
| MDR Report Key | 956750 |
| Report Source | 00,01,08 |
| Date Received | 2007-11-30 |
| Date of Report | 2007-11-02 |
| Date Mfgr Received | 2007-11-02 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-03-13 |
| 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 | 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 | HALL LARGE BONE OSCILLATING BLADE |
| Generic Name | OSCILLATING BLADE |
| Product Code | DZH |
| Date Received | 2007-11-30 |
| Returned To Mfg | 2007-11-28 |
| Model Number | NA |
| Catalog Number | 00507158200 |
| Lot Number | BBD24642 |
| ID Number | NA |
| Device Expiration Date | 2012-08-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 953474 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-30 |