MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for UNK MAMMARY IMPLANT manufactured by Allergan (costa Rica).
[186283718]
Allergan did not submit this mdr within 30 days of becoming aware. Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume. Allergan is implementing a plan to address the increased volumes. The events of seroma-late and drainage are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Reason for reoperation: seroma-late and drainage.
Patient Sequence No: 1, Text Type: N, H10
[186283719]
Patient reported right side confirmed leakage,? Breast on both side is growing and collecting fluid?. Device remains implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2020-04478 |
| MDR Report Key | 9907158 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2019-10-04 |
| Date Added to Maude | 2020-03-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE BURGESS |
| Manufacturer Street | 12331-A RIATA TRACE PARKWAY BUILDING 3 |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (COSTA RICA) |
| Manufacturer Street | 900 PARKWAY GLOBAL PARK ZONA FRANCA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK MAMMARY IMPLANT |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | FWM |
| Date Received | 2020-03-31 |
| Catalog Number | UNK MAMMARY IMPLANT |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (COSTA RICA) |
| Manufacturer Address | 900 PARKWAY GLOBAL PARK ZONA FRANCA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |