MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-13 for NO DEVICE manufactured by Allergan (medford).
[47214769]
The device has not been returned. Therefore, no analysis or testing has been done. The event of inadequate tissue ingrowth 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.
Patient Sequence No: 1, Text Type: N, H10
[47214770]
Healthcare professional reported seri surgical scaffold was placed in the right breast during mastopexy on (b)(6) 2014. Post-implantation, the device "did not absorb", and was removed on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[51516848]
Investigation has determined that the information submitted in medwatch report 8020862-2016-00032 was duplicated in this report. All additional information regarding this device will be submitted under this report number 8020862-2016-00032.
Patient Sequence No: 1, Text Type: N, H10
[51516849]
Investigation has determined that the information submitted in medwatch report 8020862-2016-00032 was duplicated in this report. All additional information regarding this device will be submitted under report number 8020862-2016-00032.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00033 |
| MDR Report Key | 5719974 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-13 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-05-22 |
| Date Mfgr Received | 2016-07-11 |
| Date Added to Maude | 2016-06-13 |
| 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 (MEDFORD) |
| Manufacturer Street | 200 BOSTON AVENUE |
| Manufacturer City | MEDFORD MA 02155 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02155 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NO DEVICE |
| Generic Name | - |
| Product Code | OXF |
| Date Received | 2016-06-13 |
| Catalog Number | NO DEVICE |
| Lot Number | NI |
| 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 (MEDFORD) |
| Manufacturer Address | 200 BOSTON AVENUE MEDFORD MA 02155 US 02155 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-13 |