MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-24 for TARSYS TS-121040 manufactured by Cook Biotech.
[5730250]
Health care professional reported post-operative inflammation and possible allergic reaction from suspected use of subject device.
Patient Sequence No: 1, Text Type: D, B5
[13045552]
Upon receipt of initial report from the health care professional - the mfr conducted a review of device history records and device sterilization processing records for lot lb 775721 which revealed no anomalies. Device is singled-use and was not returned for eval. Should the device be returned at a later date a follow-up med-watch report will be filed with subsequent eval results. A review of the mfg complaint handling system database confirms this to be the only reported event of this nature for this device family since the device was first placed into commerical distribution (b)(6) 2005.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002083993-2015-00001 |
| MDR Report Key | 4657055 |
| Report Source | 05 |
| Date Received | 2015-03-24 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-02-25 |
| Date Mfgr Received | 2015-02-25 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-04-06 |
| 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 Street | 3184-B AIRWAY AVE |
| Manufacturer City | COSTA MESA CA 92626 |
| Manufacturer Country | US |
| Manufacturer Postal | 92626 |
| Manufacturer Phone | 8005353545 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARSYS |
| Generic Name | EYELID SPACER/GRAFT. BIOLOGIC |
| Product Code | NXM |
| Date Received | 2015-03-24 |
| Model Number | TS-121040 |
| Catalog Number | TS-121040 |
| Lot Number | LB775721 |
| ID Number | NA |
| Device Expiration Date | 2016-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | WEST LAFAYETTE IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-24 |