MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-03-04 for VARADY VARIX EXTRACTOR W/HOOK 180MM FB121R manufactured by Aesculap Ap & Co. Kg.
[17575113]
Country of complaint: (b)(6). Varady hook tip broke. Fragment (sterile and blunt) left in pt, found on x-ray after surgery. Surgeon and pt are satisfied w/result.
Patient Sequence No: 1, Text Type: D, B5
[17702278]
Mfg site eval: material and hardness test results indicate product is w/in spec. The break is a spontaneous force fracture; mechanical overload. No product deviations found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00179 |
| MDR Report Key | 4617965 |
| Report Source | 01,07 |
| Date Received | 2015-03-04 |
| Date of Report | 2015-03-04 |
| Date Mfgr Received | 2015-02-04 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-05-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AP & CO. KG |
| Manufacturer Street | P.O. BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARADY VARIX EXTRACTOR W/HOOK 180MM |
| Generic Name | VEIN STRIPPER |
| Product Code | GAI |
| Date Received | 2015-03-04 |
| Model Number | FB121R |
| Catalog Number | FB121R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AP & CO. KG |
| Manufacturer Address | TUTTLINGEN DE 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-04 |