MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-21 for APPLIED MEDICAL RESOURCES A1704 manufactured by Applied Medical Resources.
[63327799]
Avid medical is the manufacturer of a custom procedure tray that contains the following medical device: clips, spring surgical stealth, part no. A1704 supplied by (b)(4). Avid medical received a complaint on 11/30/2016 originated by (b)(6) stating that during the case the clips repeatedly flew off the end of patient? S vein each time they tried to dilate, not seeming to perform up to the standard needed to do the surgery. The complained clip was not available for evaluation. Avid medical issued formal complaint (b)(4) to the supplier for non- functioning clips from manufacturer lot no. 1184100. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1047429-2016-00021 |
| MDR Report Key | 6196506 |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-11-28 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-12-21 |
| 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 | SHARON MOLL |
| Manufacturer Street | 9000 WESTMONT DR. |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APPLIED MEDICAL RESOURCES |
| Generic Name | CLIP, VASCULAR |
| Product Code | DSS |
| Date Received | 2016-12-21 |
| Model Number | A1704 |
| Lot Number | 1184100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-21 |