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 2020-03-27 for UNK TISSUE EXPANDER manufactured by Unknown Manufacturer.
[186282091]
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 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
[186282092]
Patient reported a left side infection. Device has been explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2020-06345 |
| MDR Report Key | 9889969 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2019-09-03 |
| Date Added to Maude | 2020-03-27 |
| 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 | UNKNOWN MANUFACTURER |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK TISSUE EXPANDER |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-27 |
| Catalog Number | UNK TISSUE EXPANDER |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN MANUFACTURER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |