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 2016-05-26 for SERI SURGICAL SCAFFOLD (US) SCF10X25AGEN manufactured by Allergan (medford).
[46061231]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of chronic drainage 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. The device has not been returned therefore no analysis or testing has been done.
Patient Sequence No: 1, Text Type: N, H10
[46061232]
Healthcare professional reported placement of seri? Surgical scaffold on (b)(6) 2014 during a mammoplasty procedure. Post-implantation and beginning (b)(6) 2014, the patient presented with "chronic wound drainage". The physician decided to remove the scaffold on (b)(6) 2015 and discovered completely unincorporated seri? Surgical scaffold. The device was completely removed.
Patient Sequence No: 1, Text Type: D, B5
[50590914]
Medwatch sent to fda on 07/19/2016. Additional information: describe event or problem, other relevant history, evaluation codes, additional mfr narrative.
Patient Sequence No: 1, Text Type: N, H10
[50590915]
Healthcare professional provided additional information that described bilateral "sterile abscesses" as an additional symptom.
Patient Sequence No: 1, Text Type: D, B5
[61358779]
Additional and corrected information: device manufacture date. Further investigation summary: according to the information gathered during the investigation, there is enough evidence to support that, for devices from lot p13072201a all non-conformances were addressed and were determined to have no impact on product quality and safety. There is no evidence in the manufacturing history of lot p13072201a to suggest that a manufacturing error caused the adverse events reported.
Patient Sequence No: 1, Text Type: N, H10
[61358780]
Healthcare professional reported placement of seri surgical scaffold on (b)(6) 2014 during a mammoplasty procedure. Post-implantation and beginning (b)(6) 2014, the patient presented with "chronic wound drainage". The physician decided to remove the scaffold on (b)(6) 2015 and discovered completely unincorporated seri surgical scaffold. The device was completely removed. Healthcare professional provided additional information that described bilateral "sterile abscesses" as an additional symptom. ..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00031 |
| MDR Report Key | 5683171 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-26 |
| Date of Report | 2016-12-02 |
| Date of Event | 2014-09-23 |
| Date Mfgr Received | 2016-11-05 |
| Device Manufacturer Date | 2013-08-30 |
| Date Added to Maude | 2016-05-26 |
| 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 | 2016-05-26 |
| Catalog Number | SCF10X25AGEN |
| Lot Number | P13072201A |
| Device Expiration Date | 2016-07-31 |
| 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 | 2016-05-26 |