MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-14 for PECTORAL 4 (AIACHE) SIZE 3, RIGHT 550-631RT manufactured by Spectrum Designs, Inc..
[2632548]
On (b)(6) 2011, dr. (b)(6) performed surgery to implant a pair of pectoral implants on the pt. Two days after surgery, on (b)(6) 2011, the pt allegedly complained to his physician of pain at the incision site. On (b)(6) 2012, the pt began treatment for infection on the right pectoral with antibiotics. On (b)(6) 2012, spectrum designs medical was notified by the office of dr. (b)(6) of the infection in the pectoral region, and that replacement pectoral implants were required for surgery scheduled on (b)(6) 2012. The physician performed explant and re-implantation of both the left and right solid silicone pectoral implants on the date (b)(6) 2012. The implants that were requested by dr. (b)(6) office for replacement of the originals, were not of the same model and size as the originals, therefore, both pectorals were replaced, rather than replacing only the right side due to infection.
Patient Sequence No: 1, Text Type: D, B5
[9760768]
Spectrum design medical has reviewed all lots and sterilization data related to the devices involved in this adverse event, and there is no evidence that the device was the root cause of the event. No other complaints of infection have been received related to these two device manufactured lots, or sterilization lots. The investigation concluded that the infection was due to complications of the surgical procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028306-2012-00002 |
| MDR Report Key | 2498289 |
| Report Source | 05 |
| Date Received | 2012-03-14 |
| Date of Report | 2012-03-12 |
| Date of Event | 2012-02-17 |
| Date Mfgr Received | 2012-02-20 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-03-22 |
| 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 Street | 6387 B ROSE LN. |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8056847678 |
| Manufacturer G1 | SPECTRUM DESIGNS, INC. |
| Manufacturer Street | 6387 B ROSE LN. |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93013 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PECTORAL 4 (AIACHE) SIZE 3, RIGHT |
| Generic Name | SOLID SILICONE PECTORAL IMPLANT, STERILE |
| Product Code | MIC |
| Date Received | 2012-03-14 |
| Model Number | 550-631RT |
| Catalog Number | 550-631RT |
| Lot Number | 33686 |
| Device Expiration Date | 2014-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRUM DESIGNS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-14 |