MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-02-23 for STYLE 410 MM RE-STERILIZABLE SIZER N-SZMM360 manufactured by Allergan (costa Rica).
[68123023]
It was not possible to fully investigate or confirm the alleged event as the product was not returned to allergan for analysis. Follow-up will be performed to request device return. If device is returned, it will be analyzed and results sent to the fda in a supplemental report. Device history record results: review of dhr for work order (b)(4) did not identify any errors, omissions or non-conformances that may be associated with the reported device event. All re-sterilizable sizers were reviewed as part of the assembly operations and these tasks were performed according to applicable current procedures to ensure that assembly met the required specifications. Deviation number (b)(4) was referenced in dhr record for work order (b)(4); this deviation is related to an incorrect weight registry, however there is no impact to the devices as this work order was not related to the deviation and it was associated only as a containment measure. Additionally all the order weight were checked an confirmed to be within specifications also, these defects have no relation with the reported event. The dhr assembly report from sap was verified and three devices were scrapped during the assembly process (1 at, 1 dc, 1 fi) which are not related to the reported event. According to the information gathered during the dhr review, there is enough evidence to support that devices from work order (b)(4) were assembled in accordance with allergan medical procedures and specifications. The reported device was intact at the time of production and met the required specifications. Device labeling: each sizer is supplied sterile in a sealed, double package. Sterility of the sizer is maintained only if the packages, including the package seals, are intact. Do not use the product if the packages or seals have been damaged.
Patient Sequence No: 1, Text Type: N, H10
[68123024]
Physician reports they opened a new sizer pack and found a foreign body in the package, looking like a piece of cling wrap. The device was not implanted.
Patient Sequence No: 1, Text Type: D, B5
[73723892]
Results of device analysis: visual analysis of the returned device identified: fold creases, weight measurement within specification, white and brown particles on shell surface, and also identified a particle with the following characteristics: transparent color, measured 3. 0 cm approximately, irregular shape and smooth type. Additional visual analysis identified bubbles on gel (after autoclave cycle) and a particle above the specification according to qa199. 12. (specification: no particle greater than (>) 1mm inside package. ) based on the device analysis, the final assessment is: a particle found above the nominal specification. Device history record was raised due to particle observed above specification: review of dhr for this work order did not identify any deviations, errors, omissions or non-conformances during manufacturing process. All re-sterilizable sizer were reviewed as part of the assembly operations and these tasks were performed according to applicable current procedures to ensure that assembly met the required specifications. Counter measure for ncmr number (b)(4) was referenced in dhr record for work order number (b)(4); this counter measure is related to primary package weight process. Also, these counter measure have no relation with the reported event. The dhr assembly report from sap was verified and 3 device were scrapped during the assembly process (1at, 1dc, 1fi) which are not related to the reported event. Further investigation was raised due to particle observed above specification: according to the information gathered during the investigation, there is enough evidence to support that devices from work order (b)(4) were assembled in accordance with allergan medical procedures and specifications. The reported device was intact at the time of production and met the required specifications. During the device analysis it was observed like a piece of plastic on shell surface, it is out of specification according to (b)(4). Considering that there is not an adverse trend for this type of event no additional actions are deemed required at this time. The issue with foreign material on implant will continue to be monitored and corrective action taken in the future if deemed appropriate.
Patient Sequence No: 1, Text Type: N, H10
[73723893]
Physician reports they opened a new sizer pack and found a foreign body in the package, looking like a piece of cling wrap. The device was not implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2017-00112 |
| MDR Report Key | 6352640 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-02-23 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-03-16 |
| Device Manufacturer Date | 2016-11-07 |
| Date Added to Maude | 2017-02-23 |
| 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 | 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 | STYLE 410 MM RE-STERILIZABLE SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2017-02-23 |
| Returned To Mfg | 2017-03-13 |
| Catalog Number | N-SZMM360 |
| Lot Number | 2985252 |
| 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 | 2017-02-23 |