MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-10 for SERI SURGICAL SCAFFOLD (US) SCF15X25AGEN manufactured by Allergan (medford).
[69611220]
Further information from the reporter regarding this event has been requested. No additional information is available at this time. The reported events of seroma, inadequate tissue ingrowth, and capsular contracture, baker grade iii, 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
[69611221]
Physician reported a patient with seri? Surgical scaffold experienced right side capsular contracture, baker grade iii and? There were areas of fluid collection of thickened capsule?. Physician noted? The seri? Silk scaffold was incorporated; however, it was removable by gentle peeling away with an underlying granulation tissue and release of ethibond sutures?.
Patient Sequence No: 1, Text Type: D, B5
[74383642]
Patient Sequence No: 1, Text Type: N, H10
[74383643]
Additional information received from healthcare professional that the events have resolved without sequelae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2017-00003 |
| MDR Report Key | 6395381 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-10 |
| Date of Report | 2017-05-03 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2014-12-31 |
| Date Added to Maude | 2017-03-10 |
| 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 | 2017-03-10 |
| Catalog Number | SCF15X25AGEN |
| Lot Number | P14100101A |
| Device Expiration Date | 2017-11-30 |
| 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 | 2017-03-10 |