MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-30 for ALLIED BIOMEDICAL * CCB1-3 manufactured by Implantech Associates.
[251437]
Surgeon implanted "non-sterile" carving block without sterilizing unit. O. R. Staff did not notice "non-sterile" labeling. Upon realization that unit was "non-sterile", implant was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2002-00001 |
| MDR Report Key | 419860 |
| Report Source | 05 |
| Date Received | 2002-09-30 |
| Date of Report | 2002-09-23 |
| Date of Event | 2002-08-30 |
| Date Mfgr Received | 2002-09-06 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2002-10-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN MEADE |
| Manufacturer Street | 2064 EASTMAN AVE #101 |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLIED BIOMEDICAL |
| Generic Name | SILICONE CARVING BLOCK |
| Product Code | MIB |
| Date Received | 2002-09-30 |
| Model Number | * |
| Catalog Number | CCB1-3 |
| Lot Number | 800049 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 408913 |
| Manufacturer | IMPLANTECH ASSOCIATES |
| Manufacturer Address | 2064 EASTMAN AVE. #101 VENTURA CA 93003 US |
| Baseline Brand Name | ALLIED BIOMEDICAL BLOCK |
| Baseline Generic Name | SILICONE ELASTOMER BLOCK |
| Baseline Catalog No | CCB1-3 |
| Baseline Device Family | FACIAL IMPLANT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K952706 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-09-30 |