MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for BREAST IMPLANT manufactured by Allergan.
[78465450]
A removal of a possible defective breast implant. We contacted allergan's product surveillance dept, and we have opened a claim and a return kit will be sent to us tomorrow morning to send product back to them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070614 |
| MDR Report Key | 6666699 |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-06-20 |
| Date Added to Maude | 2017-06-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | BREAST IMPLANT |
| Generic Name | BREAST IMPLANT |
| Product Code | MRD |
| Date Received | 2017-06-22 |
| Returned To Mfg | 2017-06-22 |
| Lot Number | 2533524 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-22 |