MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-07 for SERI SURGICAL SCAFFOLD (US) SCF15X25AGEN manufactured by Allergan (medford).
[56920558]
(b)(4). 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 "possible infection", "inflammation", "purulent drainage", capsular contracture (baker grade iv), and "not integrated" 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. "device labeling addresses the reported event of infection and inflammation 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
[56920559]
Physician reported a procedure to correct left side breast capsular contracture occurring on (b)(6) 2016. The physician noted "possible infection", inflammation, "purulent drainage", capsular contracture (baker grade iv), and "not integrated" for a left side seri scaffold during the procedure. Seri and the concomitantly placed silicone gel breast implant were explanted.
Patient Sequence No: 1, Text Type: D, B5
[61127127]
Additional data: age/date of birth, date of event, describe event or problem, relevant tests/lab data, brand name, model #/lot #, implant date, device manufacture date. Corrected data: relevant tests/lab data.
Patient Sequence No: 1, Text Type: N, H10
[61127128]
Events have resolved without sequelae as of 09/31/2016.
Patient Sequence No: 1, Text Type: D, B5
[69008473]
From the review of the device history records for lot p14071801, there is no evidence in the manufacturing history of lot p14071801 to suggest that a manufacturing error caused the adverse event reported.
Patient Sequence No: 1, Text Type: N, H10
[69008474]
Physician reported a procedure to correct left side breast capsular contracture occurring on (b)(6) 2016. The physician noted "possible infection", inflammation, "purulent drainage", capsular contracture (baker grade iv), and "not integrated" for a left side seri? Scaffold during the procedure. Seri? And the concomitantly placed silicone gel breast implant were explanted. Events have resolved without sequelae as of (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00045 |
| MDR Report Key | 6011976 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-07 |
| Date of Report | 2017-03-02 |
| Date of Event | 2016-08-24 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2014-08-31 |
| Date Added to Maude | 2016-10-07 |
| 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 | 2016-10-07 |
| Catalog Number | SCF15X25AGEN |
| Lot Number | P14071801A |
| Device Expiration Date | 2017-07-31 |
| 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 | 2016-10-07 |