MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-13 for FLOWERS EXTENDED TEAR TROUGH IMPLANT, LARGE EFTT-L manufactured by Implantech Associates Inc..
[19968563]
Complainant reported that implant tore in the middle of surgery. Complainant indicated pt was under anesthesia and requested another device be couriered to them asap to complete the surgery. Repeated attempts to obtain more detailed info from the complainant have been unsuccessful. The info that was provided regarding product id is questionable and unverified by physical examination of the product. No injury has been reported concerning this event, however the implication that a potential malfunction of the device may have lead to an extension in the duration of surgery was considered in implantech's reporting decision.
Patient Sequence No: 1, Text Type: D, B5
[20262577]
Method: reviewed product labeling and complaint trending info for subject device. Review of the complaint history found no prior history of any similar events for the subject device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2013-00005 |
| MDR Report Key | 3724736 |
| Report Source | 05 |
| Date Received | 2013-12-13 |
| Date of Report | 2013-12-13 |
| Date of Event | 2013-11-15 |
| Date Mfgr Received | 2013-11-15 |
| Date Added to Maude | 2014-05-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE MEADE |
| Manufacturer Street | 6025 NICOLLE ST., SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8503399415 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOWERS EXTENDED TEAR TROUGH IMPLANT, LARGE |
| Generic Name | TEAR TROUGH IMPLANT |
| Product Code | LZK |
| Date Received | 2013-12-13 |
| Model Number | NA |
| Catalog Number | EFTT-L |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES INC. |
| Manufacturer Address | VENTURA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-13 |