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 2019-02-19 for UNK SIZER (RESTERILIZABLE) manufactured by Allergan (costa Rica).
[136535662]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. This is a known potential adverse event addressed in the product labeling.
Patient Sequence No: 1, Text Type: N, H10
[136535663]
Patient reported a rupture on an unknown side. Device was explanted.
Patient Sequence No: 1, Text Type: D, B5
[139912788]
Device evaluation: visual analysis of the returned device identified two curved openings. A microscopic analysis was performed which identified two sharp openings. A thickness measurement was not performed because the catalog is unknown. Based on the device analysis the final assessment is: two sharp openings assessed as unidentified tear opening.
Patient Sequence No: 1, Text Type: N, H10
[139912789]
Patient reported a rupture on an unknown side. Device was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2019-00802 |
| MDR Report Key | 8351595 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-19 |
| Date of Report | 2019-03-25 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-02-19 |
| 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 | 301 W HOWARD LANE SUITE 100 |
| Manufacturer City | AUSTIN TX 78753 |
| Manufacturer Country | US |
| Manufacturer Postal | 78753 |
| 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 SIZER (RESTERILIZABLE) |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2019-02-19 |
| Returned To Mfg | 2019-02-11 |
| Catalog Number | UNK SIZER (RESTERILIZABLE) |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-19 |