MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-31 for UNK SALINE IMPLANT manufactured by Allergan (costa Rica).
[187906200]
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. In response to fda report number: mw5089689. 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: deflation.
Patient Sequence No: 1, Text Type: N, H10
[187906201]
Patient, via regulatory agency, reported bilateral "ruptures",? Chest pain, breast pain, burning around breast area, relentless sharp pain in my right breast? And anxiety. Patient also reported fibromyalgia, low energy,? Visual disturbances, vertigo, falling, brain fog, light and sound sensitivity? ,? Rashes, itching? ,? Aching joints, muscle pain, back and neck pain? ,? Brain tumor (benign), panic attacks, heart palpitations, gastroesophageal reflux disease (gerd), irritable bowel syndrome (ibs), metallic taste in mouth, night sweats, temperature intolerance, foul body odor, chemical sensitivities, and thyroid dysfunction?. These events are not device related. Device has been explanted. This record is for the left side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2020-06121 |
| MDR Report Key | 9906061 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 1999-04-01 |
| Date Mfgr Received | 2019-09-23 |
| 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 SALINE IMPLANT |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | FWM |
| Date Received | 2020-03-31 |
| Catalog Number | UNK SALINE 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 |