MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2005-05-10 for SURIGCAL SPRING CLIPS-SOFT/FIBRA, 6MM G-6050 100375101 manufactured by Applied Medical Resources Corp..
[397055]
A piece of bulldog clip came off during open heart surgery, the piece was the part where the applier concepts to the bulldog. Doctor could not retrieve it. Pt is fine but lost piece was assured to be in pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2005-00005 |
| MDR Report Key | 601637 |
| Report Source | 00,05 |
| Date Received | 2005-05-10 |
| Date of Event | 2005-05-02 |
| Report Date | 2005-05-03 |
| Date Reported to FDA | 2005-05-03 |
| Date Reported to Mfgr | 2005-04-06 |
| Date Added to Maude | 2005-05-13 |
| 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 | CARMEN FLORES |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138444 |
| Manufacturer G1 | APPLIED MEDICAL RESOURCES |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURIGCAL SPRING CLIPS-SOFT/FIBRA, 6MM |
| Generic Name | SURGICAL SPRING CLIPS |
| Product Code | DSS |
| Date Received | 2005-05-10 |
| Model Number | G-6050 |
| Catalog Number | 100375101 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 591457 |
| Manufacturer | APPLIED MEDICAL RESOURCES CORP. |
| Manufacturer Address | * RANCHO SANTA MARGARITA CA * US |
| Baseline Brand Name | SURGICAL SPRING CLIP, 6MM, SOFT/FIBRA |
| Baseline Generic Name | SURGICAL SPRING CLIP |
| Baseline Model No | G-6050 |
| Baseline Catalog No | G-6050 |
| Baseline ID | 100064301 |
| Baseline Device Family | SURGICAL SPRING CLIP |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K901628 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-10 |