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 2016-09-09 for SERI SURGICAL SCAFFOLD (US) SCF10X25AGEN manufactured by Allergan (medford).
[54285840]
The physician discarded the device when it was explanted and it is no longer available for return. Therefore analysis or testing is not able to be done. The events of seroma, cellulitis, capsular contracture, and inadequate tissue ingrowth are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events. 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
[54285841]
Physician reported right side cellulitis, capsular contracture (baker grade iv), seroma, and unincorporated seri scaffold. Seri was implanted concomitantly with non-allergan saline breast implants during reconstruction revision surgery on (b)(6) 2014. The patient was hospitalized and treated with iv antibiotics after oral antibiotic treatments were ineffective. The patient was then scheduled for surgery and the devices were removed on (b)(6) 2015. The symptoms resolved without sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00044 |
| MDR Report Key | 5938861 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-09-09 |
| Date of Report | 2016-08-10 |
| Date of Event | 2015-10-27 |
| Date Mfgr Received | 2016-08-10 |
| Date Added to Maude | 2016-09-09 |
| 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 | 2016-09-09 |
| Catalog Number | SCF10X25AGEN |
| Lot Number | NI |
| 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. Hospitalization; 2. Required No Informationntervention | 2016-09-09 |