MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-10-04 for RND RE-STER SIZER 45, 460 MSZ45460 manufactured by Allergan (costa Rica).
[56375324]
Medwatch submitted to the fda on 10/04/2016. It is currently unknown if the device will be returned for further analysis. Device history record (dhr) reviewed. Dhr summary: review of dhr for work order (b)(4) did not identify any deviations, errors, omissions or non-conformances that may be associated with the reported device event. All breast implant 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. Dhr for work order (b)(4) indicates that there was a reprocess on the primary packaging operation. The reported device was reprocessed through work order (b)(4) and any deviations, errors, omissions or non-conformances were identified that may be associated with the reported device event. Dhr for work order (b)(4) indicates that there was a reprocess in the primary packaging operation, however this was completed on a different serial number and this has no relation neither can cause the reported event. The dhr assembly report from sap was verified and one device was scrapped during the assembly process (gs) which is not related to the reported event. In addition, dhr for shell run number (b)(4) did not identify any deviations, errors, omissions or non-conformances that may be associated with the reported device event. All shells were reviewed as part of the shell fabrication operations and these tasks were performed according to applicable current procedures to ensure that fabrication met the required specifications. 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: natrelle? Re-sterilizable sizers are intended for a maximum ten (10) additional uses after initial use following validated procedures for cleaning, disinfecting and re-sterilization. Complete sizer re-sterilization record card provided with the device after each re-sterilization process. The name of person performing the re-sterilization and date of re-sterilization should be recorded on the card. The sizer re-sterilization record card should accompany the device at all times. Repeat use these products are intended for ten (10) additional uses after initial use and only after adequate cleaning, disinfecting and re-sterilization by validated techniques. Do not reuse re-sterilizable sizers more than ten (10) times after initial use.
Patient Sequence No: 1, Text Type: N, H10
[56375325]
Company representative reported on behalf of health professional that a resterilizable sizer "busted" while being inserted into a patient. The sizer had been previously used 8 times. Follow up findings revealed gel made contact with the patient as the physician had to clean out the pocket after removing the "busted" sizer. Surgery was completed with a back-up sizer.
Patient Sequence No: 1, Text Type: D, B5
[58211212]
Medwatch submitted to the fda on 10/11/2016. Received confirmation from the physician's office that the explanted device was discarded and, therefore, is not available for further analysis. Additional data: device available for evaluation?. , evaluation codes.
Patient Sequence No: 1, Text Type: N, H10
[58211213]
Company representative reported on behalf of health professional that a resterilizable sizer "busted" while being inserted into a patient. The sizer had been previously used 8 times. Follow up findings revealed gel made contact with the patient as the physician had to clean out the pocket after removing the "busted" sizer. Surgery was completed with a back-up sizer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617229-2016-00136 |
| MDR Report Key | 5996665 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-04 |
| Date Mfgr Received | 2016-10-06 |
| Device Manufacturer Date | 2012-04-24 |
| Date Added to Maude | 2016-10-04 |
| 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 | RND RE-STER SIZER 45, 460 |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2016-10-04 |
| Catalog Number | MSZ45460 |
| Lot Number | 2269085 |
| Device Expiration Date | 2017-03-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-10-04 |