MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-01 for 7000 ROUND STYLE CATALOG NO 360-7225 SIZE 225 CC + 25 manufactured by Heyer Schulte Corporation.
[4089]
Patient treated at user facility by removal of ruptured breast implant(s) - bilateraldevice labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5822 |
| MDR Report Key | 5822 |
| Date Received | 1993-07-01 |
| Date of Report | 1993-06-04 |
| Report Date | 1993-06-04 |
| Date Reported to FDA | 1993-06-04 |
| Date Added to Maude | 1993-07-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7000 ROUND STYLE |
| Product Code | GAH |
| Date Received | 1993-07-01 |
| Model Number | CATALOG NO 360-7225 |
| Catalog Number | SIZE 225 CC + 25 |
| Lot Number | LEFT 202829 RT 202829 |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 5521 |
| Manufacturer | HEYER SCHULTE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-01 |