MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-11-26 for SURGITEK PECTORALIS IMPLANT 0037000 NA manufactured by Medical Engineering Corp..
[20244707]
Allegation of unspecified injuries due to implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182596-1997-00859 |
| MDR Report Key | 135393 |
| Report Source | 00 |
| Date Received | 1997-11-26 |
| Date of Report | 1997-11-07 |
| Date Mfgr Received | 1997-11-07 |
| Device Manufacturer Date | 1988-07-01 |
| Date Added to Maude | 1997-12-03 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGITEK PECTORALIS IMPLANT |
| Generic Name | PECTORALIS IMPLANT |
| Product Code | MIC |
| Date Received | 1997-11-26 |
| Model Number | 0037000 |
| Catalog Number | NA |
| Lot Number | 55431-88G |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 132282 |
| Manufacturer | MEDICAL ENGINEERING CORP. |
| Manufacturer Address | 2317 EATON LANE RACINE WI 53404 US |
| Baseline Brand Name | SURGITEK PECTORALIS IMPLANT |
| Baseline Generic Name | PECTORALIS IMPLANT |
| Baseline Model No | 0037000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-11-26 |