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 2016-12-13 for SERI SURGICAL SCAFFOLD (US) SCF15X25AGEN manufactured by Allergan (medford).
[62239885]
The events of fluid drainage and "did not incorporate" are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events. The device will not be returned as it has been discarded. Therefore, no analysis or testing can be done.
Patient Sequence No: 1, Text Type: N, H10
[62239886]
Physician reported bilateral seri? Surgical scaffold "did not integrate". Seri? Was used to support concomitantly placed silicone gel breast implants. On (b)(6) 2016, seri? Surgical scaffold was placed? As a sling?. The patient experienced? Fluid drainage? On (b)(6) 2016 and underwent exploratory surgery to address the drainage on (b)(6) 2016, at which time seri? Was found to be "non-incorporated. " on (b)(6) 2016, left side seri? Scaffold was removed. No integration was noted and the entirety of the product was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00049 |
| MDR Report Key | 6169880 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-13 |
| Date of Report | 2016-12-13 |
| Date Mfgr Received | 2016-11-17 |
| Device Manufacturer Date | 2014-09-30 |
| Date Added to Maude | 2016-12-13 |
| 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 | 2016-12-13 |
| Catalog Number | SCF15X25AGEN |
| Lot Number | P14073101A |
| Device Expiration Date | 2017-08-31 |
| 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 | 2016-12-13 |