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 2020-03-29 for STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB 133MV-13-T manufactured by Allergan (austin).
[186550147]
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: mw5089373. The event of infection is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. 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: infection (unknown onset).
Patient Sequence No: 1, Text Type: N, H10
[186550148]
Patient reported an unknown side for a tissue expander "feeling sick in may, severe fatigue. Nausea i vomiting. Hot/cold spells, temperatures, loss of appetite, overall feeling very bad," "receive lab work multiple times, all showing i had an infection going on, "when seen in the emergency room, after seeing my right breast two times the size of the left, extremely red and very hot to the touch, temps at 103-104. Was diagnosed with severe sepsis, septic shock, and was taken to surgery for immediate removal of my implants and expanders. " this record will be for the right side. Device has been explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2020-04743 |
| MDR Report Key | 9896273 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date of Event | 2019-05-15 |
| Date Mfgr Received | 2019-08-26 |
| Date Added to Maude | 2020-03-29 |
| 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 (AUSTIN) |
| Manufacturer Street | 12331-A RIATA TRACE PARKWAY BUILDING 3 |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-29 |
| Catalog Number | 133MV-13-T |
| 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 (AUSTIN) |
| Manufacturer Address | 12331-A RIATA TRACE PARKWAY BUILDING 3 AUSTIN TX 78727 US 78727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-29 |