MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-24 for SPECTRUM PREFORMED BLOCK BLOCK 1 650-151 manufactured by Spectrum Designs Medical.
[317536]
Physician's office autoclaved the pre-formed implants. The vacuum portion of the autoclave cycle resulted in some bubbles and ruptures to the implant. The pt subsequently developed an infection. The implant was removed and the pt is now doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028306-2003-00001 |
| MDR Report Key | 491714 |
| Date Received | 2003-10-24 |
| Date of Report | 2003-10-21 |
| Date of Event | 2003-06-10 |
| Date Mfgr Received | 2003-06-11 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2003-10-29 |
| 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 | JIM DISHMAN, PRESIDENT |
| Manufacturer Street | 6387 B ROSE LANE |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRUM PREFORMED BLOCK |
| Generic Name | PREFORMED SILICONE BLOCK |
| Product Code | MIB |
| Date Received | 2003-10-24 |
| Model Number | BLOCK 1 |
| Catalog Number | 650-151 |
| Lot Number | 8942 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 480414 |
| Manufacturer | SPECTRUM DESIGNS MEDICAL |
| Manufacturer Address | 6387 B ROSE LN. CARPINTERIA CA 93013 US |
| Baseline Brand Name | SPECTRUM PREFORMED BLOCK |
| Baseline Generic Name | PREFORMED SILICONE BLOCK |
| Baseline Model No | BLOCK 1 |
| Baseline Catalog No | 650-151 |
| Baseline ID | NA |
| Baseline Device Family | PREFORM CONTOUR SILICONE CARVING BLOCK |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K982688 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-10-24 |