MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2004-07-13 for PARALLEL JAW SPRING CLIP CPARAL6 NA manufactured by Edwards Lifesciences.
[17802661]
It was reported that the thumb pad had broken off and fell into the pt. The doctor was not able to find the loose piece. The pt was reported as doing well and was discharged from the hosp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000002-2004-00157 |
| MDR Report Key | 535154 |
| Report Source | 01,05,06,07 |
| Date Received | 2004-07-13 |
| Date of Report | 2004-06-15 |
| Date of Event | 2004-06-15 |
| Date Facility Aware | 2004-06-15 |
| Report Date | 2004-06-15 |
| Date Mfgr Received | 2004-06-15 |
| Device Manufacturer Date | 2003-12-01 |
| Date Added to Maude | 2004-07-22 |
| 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 | ALLISON MEZZANATTO |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502562 |
| Manufacturer G1 | EDWARDS LIFESCIENCES |
| Manufacturer Street | PARQUE INDUSTRIAL ITABO ZONA FRANCE |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARALLEL JAW SPRING CLIP |
| Generic Name | PARALLEL JAW SPRING CLIP 6MM |
| Product Code | ECO |
| Date Received | 2004-07-13 |
| Returned To Mfg | 2004-06-28 |
| Model Number | CPARAL6 |
| Catalog Number | NA |
| Lot Number | 58153678 |
| ID Number | NA |
| Device Expiration Date | 2008-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 524404 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | PARQUE INDUSTRIAL ITABO ZONA FRANCE HAINA, SAN CRISTOBAL DR |
| Baseline Brand Name | PARALLEL JAW SPRING CLIP |
| Baseline Generic Name | PARALLEL JAW SPRING CLIP 6MM |
| Baseline Model No | CPARAL6 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-07-13 |