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 2016-07-19 for SERI SURGICAL SCAFFOLD (US) SCF15X25AGEN manufactured by Allergan (medford).
[49897855]
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. The physician discarded the device when it was explanted and it is no longer available for return. Therefore allergan will not receive it and no analysis or testing will be done.
Patient Sequence No: 1, Text Type: N, H10
[49897856]
Healthcare professional reported bilateral placement of seri? Surgical scaffold for? Pectoralis extension? During mastectomy reconstruction surgery on (b)(6) 2015. ? Unincorporated? Seri? Scaffold was noted during revision on (b)(6) 2016. Seri? Was explanted entirely as 100% of the device was? Unincorporated?. Concomitantly placed non-allergan breast implants remain implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00037 |
| MDR Report Key | 5805404 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-20 |
| Date Mfgr Received | 2016-06-20 |
| Date Added to Maude | 2016-07-19 |
| 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 | 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 | SERI SURGICAL SCAFFOLD (US) |
| Generic Name | MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXF |
| Date Received | 2016-07-19 |
| Catalog Number | SCF15X25AGEN |
| Lot Number | P14020601A |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-07-19 |