MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-11-07 for NATRELLE INSPIRA MP 310G RE-STER SIZER N-SZRM310 manufactured by Allergan (costa Rica).
[126435803]
A review of the device history record has been completed. No deviations or non-conformances noted. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling: patients should be advised that the sizer may rupture, releasing silicone gel into the surrounding cavity. Prior to use, examine the re-sterilizable sizer for any evidence of damage or particulate contamination. Do not use any re-sterilizable sizer that may appear to have leaks, nicks or rupture. Do not use damaged or contaminated re-sterilizable sizers. Do not use re-sterilizable sizers that have been damaged or deformed during previous surgical operations. Ensure incision is sufficiently large to facilitate insertion and avoid damage to the device. The sizer can be inserted/removed several times to assist with size selection of the permanent implant. Do not damage the re-sterilizable sizer with sharp surgical instruments such as needles and scalpels, blunt instruments such as clamps and forceps, or by overhandling and manipulation during introduction into the surgical pocket. Do not contact the sizer with disposable, capacitor-type cautery devices as damage to the device may result. Do not use excessive force during placement of the re-sterilizable sizer, especially with 410 soft touch gel-filled shaped re-sterilizable sizers. Silicone gel may be deformed due to over manipulation, resulting in deformation of the anatomical shape.
Patient Sequence No: 1, Text Type: N, H10
[126435804]
Health professional reported left side? Rupture of the device when it is inserted into the prosthetic site. " device not implanted.
Patient Sequence No: 1, Text Type: D, B5
[131545280]
Device evaluation: visual analysis of the returned device identified a broken shell. A microscopic analysis was performed which identified a striated edge opening, consistent with use of a surgical tool. Based on the device analysis the final assessment is: a striated edge opening on anterior side due to surgical damage.
Patient Sequence No: 1, Text Type: N, H10
[131545281]
Health professional reported left side? Rupture of the device when it is inserted into the prosthetic site. " device not implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2018-08519 |
| MDR Report Key | 8047759 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-11-07 |
| Date of Report | 2018-12-24 |
| Date of Event | 2018-09-28 |
| Date Mfgr Received | 2018-12-01 |
| Device Manufacturer Date | 2016-05-25 |
| Date Added to Maude | 2018-11-07 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SUZANNE WOJCIK |
| 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 | NATRELLE INSPIRA MP 310G RE-STER SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-11-07 |
| Returned To Mfg | 2018-11-07 |
| Catalog Number | N-SZRM310 |
| Lot Number | 2914655 |
| 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. Other | 2018-11-07 |