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).
[45970720]
Medwatch sent to fda on 05/26/2016. Further information from the reporter regarding event, product, and patient details has been requested. No additional information is available at this time. The events of infection, inflammation, 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 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. Device labeling addresses the reported event of infection as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion. "
Patient Sequence No: 1, Text Type: N, H10
[45970721]
Healthcare professional reported implantation of seri surgical scaffold during abdominoplasty on (b)(6) 2014. Post implantation, the device "folded on itself" and the patient developed a possible infection. Pathology indicated acute and chronic inflammation. The patient's physician found the device was unincorporated with the patient's tissue. The device was removed.
Patient Sequence No: 1, Text Type: D, B5
[61621892]
From the review of the device history records for lot p13081301a 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 p13081301a to suggest that a manufacturing error caused the ae reported.
Patient Sequence No: 1, Text Type: N, H10
[61621893]
Healthcare professional reported implantation of seri? Surgical scaffold during abdominoplasty on (b)(6) 2014. Post implantation, the device "folded on itself" and the patient developed a possible infection. Pathology indicated acute and chronic inflammation. The patient's physician found the device was unincorporated with the patient's tissue. The device was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00030 |
| MDR Report Key | 5681488 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-26 |
| Date of Report | 2016-12-06 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2016-11-07 |
| Device Manufacturer Date | 2013-09-30 |
| 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 | P13081301A |
| Device Expiration Date | 2016-08-31 |
| 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 |