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 2016-11-30 for UNK SERI SURGICAL SCAFFOLD manufactured by Allergan (medford).
[61142830]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The event of inadequate tissue ingrowth is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. The device has not been returned. Therefore, no analysis or testing has been done.
Patient Sequence No: 1, Text Type: N, H10
[61142831]
Physician reported seri? Surgical scaffold "did not incorporate" after placement during an unknown mammoplasty procedure.
Patient Sequence No: 1, Text Type: D, B5
[63641047]
Additional information: describe event or problem. Clarification to the reported event: the event is no longer reportable as non-integration is not a serious injury. Per allergan healthcare professional, the time period required by the seri device for complete integration varies and is a function of multiple variables.
Patient Sequence No: 1, Text Type: N, H10
[63641048]
Physician reported in (b)(6) 2014 patient underwent reconstruction revision at which time seri surgical scaffold was placed in the? Sling? Position to support a previously placed saline breast implant. In (b)(6) 2016, the patient underwent exchange of saline device for a silicone gel device, at which time it was noted that some portion of the ser had not integrated. The non-integrated part of the device was explanted and a new seri device was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00048 |
| MDR Report Key | 6135656 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-30 |
| Date of Report | 2016-12-29 |
| Date Mfgr Received | 2016-12-05 |
| Date Added to Maude | 2016-11-30 |
| 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 | 2016-11-30 |
| 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 | 2016-11-30 |