MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-05-18 for CONTOUR CARVING BLOCK CCB3-4 manufactured by Allied Biomedical Corp..
[170838]
Pt initially implanted with device in 2000 for augmentation in the leg. Doctor thought device had moved and repositioned device in 2000. In 2000, doctor explanted device and replaced it with a larger size. Doctor claims device is incorrect measurement as stated on labeling. Pt underwent 2nd surgery for replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030583-2000-00001 |
| MDR Report Key | 278568 |
| Report Source | 05 |
| Date Received | 2000-05-18 |
| Date of Report | 2000-05-18 |
| Date of Event | 2000-05-12 |
| Date Mfgr Received | 2000-05-12 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2000-05-23 |
| 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 | CATHERINE RIPLE, MGR |
| Manufacturer Street | 3850 RAMADA DR SUITE C-2 |
| Manufacturer City | PASO ROBLES CA 93446 |
| Manufacturer Country | US |
| Manufacturer Postal | 93446 |
| Manufacturer Phone | 8054345066 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR CARVING BLOCK |
| Generic Name | SILICONE CARVING BLOCK |
| Product Code | MIB |
| Date Received | 2000-05-18 |
| Model Number | NA |
| Catalog Number | CCB3-4 |
| Lot Number | A2826/1348 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 269629 |
| Manufacturer | ALLIED BIOMEDICAL CORP. |
| Manufacturer Address | 3850 RAMADA DR., SUITE C-2 PASO ROBLES CA 93446 US |
| Baseline Brand Name | CONTOUR CARVING BLOCK |
| Baseline Generic Name | SILICONE CARVING BLOCK |
| Baseline Model No | NA |
| Baseline Catalog No | CCB3-4 |
| Baseline ID | NA |
| Baseline Device Family | SILICONE ELASTOMER BLOCK |
| Baseline Shelf Life [Months] | NA |
| 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. Other | 2000-05-18 |