MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-23 for SPECTRUM DESIGNS MEDICAL PECTORAL 1 (AIACHE) 550-611RT/550-611LT manufactured by Spectrum Designs Medical, Inc..
[20833538]
On (b)(4) 2010, (3) of the replacement implants were returned to sdm and the implant 550-621rt ((b)(4)) lot 32472 was retained by the physician, and implanted into the patient. The left original implant was not explanted from the patient because the patient was happy with the size and shape of it, and wanted the right implant to match the left. The right explanted device 550-611rt from the original surgery did have a mold mark that the physician confirmed with sdm to match the correct catalog part number that it was labeled as. Because the left was not explanted and returned to sdm, no further investigation can be performed. Sdm can only conclude that the complaint was not due to mislabeled product, but rather patient asymmetry that was not identified prior to the original surgery by the physician. Batch records, label records, sterilization records, and mold marks were all reviewed as related to this complaint. No inconsistencies were identified.
Patient Sequence No: 1, Text Type: N, H10
[20842973]
Physician reported a patient complaint of asymmetry 7 months after initial surgery for solid silicone pectoral implants. Physician noticed some asymmetry directly after surgery, but attributed it to swelling. Patient liked the sizing of the left implant, and wanted the right to match the left. Original implants sent to dr. For this patient's surgery were a pair pectorals the same size. Physician reported no signs of asymmetry before surgery. Spectrum sent replacement implants to physician for explant/re-implantation. Pt received a new larger sized implant for the right side 550-621rt to match the left 550-611lt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028306-2010-00001 |
| MDR Report Key | 1734280 |
| Report Source | 05 |
| Date Received | 2010-06-23 |
| Date of Report | 2010-06-11 |
| Date of Event | 2010-05-10 |
| Date Mfgr Received | 2008-08-13 |
| Device Manufacturer Date | 2009-06-17 |
| Date Added to Maude | 2011-05-04 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRUM DESIGNS MEDICAL PECTORAL 1 (AIACHE) |
| Generic Name | SOLID SILICONE PECTORAL IMPLANT, STERILE |
| Product Code | MIC |
| Date Received | 2010-06-23 |
| Model Number | 550-611RT/550-611LT |
| Catalog Number | 550-611RT/550-611LT |
| Lot Number | 32747/32483 |
| Device Expiration Date | 2012-06-30 |
| 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 MEDICAL, INC. |
| Manufacturer Address | 6387 B ROSE LN. CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-23 |