MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-07 for UNK SERI SURGICAL SCAFFOLD manufactured by Allergan (medford).
[48974256]
Medwatch sent to fda on 07/07/2016. 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 infection 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. This report and report number 8020862-2016-00035 will be submitted for the same patient. This report is for the right side seri? Device. Report number 8020862-2016-00035 is for the left side seri? Device. The explanted device has not been returned. Therefore, no analysis or testing has been 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
[48974257]
Healthcare professional reported right side seri? Device with? Possible infection? And? Seri? Did not integrate.? The concomitantly placed silicone gel breast implant was explanted.
Patient Sequence No: 1, Text Type: D, B5
[50850981]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[50850982]
Healthcare professional reported additionally, "but cultures were negative- no infection found. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00036 |
| MDR Report Key | 5775810 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-07 |
| Date of Report | 2016-06-10 |
| Date of Event | 2016-04-25 |
| Date Mfgr Received | 2016-06-30 |
| Date Added to Maude | 2016-07-07 |
| 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 | UNK SERI SURGICAL SCAFFOLD |
| Generic Name | MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXF |
| Date Received | 2016-07-07 |
| Catalog Number | UNK SERI SURGICAL SCAFFOLD |
| Lot Number | NI |
| 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 | 2016-07-07 |