MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-02 for BLOCK II GLUTEAL IMPLANT 650-211T manufactured by Spectrum Designs Medical.
[4932721]
Dr. (b)(6) reported to us that he had explanted a gluteal implant in his pt that he had previously implanted in (b)(6) of 2011. He had scheduled a surgery to fix an implant that he and the pt believed had "shifted" but during surgery he found that the implant had torn in half. He then removed both of the implants, and the pt has no pains for any re-implantation of gluteal implants.
Patient Sequence No: 1, Text Type: D, B5
[12392926]
The implants were requested to be returned, however, when they were not received for eval, the physician was contacted again multiple times, and it has now been concluded that they have been discarded. Spectrum designs medical has reviewed all relevant mfg and sterilization data to the lot and there is no evidence of an error in mfg. Dr. (b)(6) implanted the only (2) implants from that lot in the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028306-2012-00004 |
| MDR Report Key | 4146649 |
| Report Source | 05 |
| Date Received | 2012-08-02 |
| Date of Report | 2012-08-01 |
| Date of Event | 2012-06-04 |
| Date Mfgr Received | 2012-07-03 |
| Date Added to Maude | 2014-10-09 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOCK II GLUTEAL IMPLANT |
| Generic Name | SOLID SILICONE GLUTEAL IMPLANT, STERILE |
| Product Code | MIB |
| Date Received | 2012-08-02 |
| Model Number | 650-211T |
| Catalog Number | 650-211T |
| Lot Number | 33677 |
| Device Expiration Date | 2013-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRUM DESIGNS MEDICAL |
| Manufacturer Address | CARPINTERIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-08-02 |