MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-02-11 for HULKA FALLOPIAN TUBE CLIP 4986.09 5986.09 manufactured by Richard Wolf Medical Instrum..
[21246287]
When a hulka fallopian tube clip was applied, it came appart in the applicator and fell into the abdominal cavity. The physician searched the abdomen and was able to grasp and remove the metal spring component. The plastic jaw section was not retrieved. Another clip was applied successfully. No additional surgery was done to recover the lost component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2004-00003 |
| MDR Report Key | 525648 |
| Report Source | 05 |
| Date Received | 2004-02-11 |
| Date of Report | 2004-01-20 |
| Date of Event | 2004-01-20 |
| Date Facility Aware | 2004-01-20 |
| Report Date | 2004-01-20 |
| Date Reported to Mfgr | 2004-01-20 |
| Date Mfgr Received | 2004-01-20 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2004-05-20 |
| 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 | JERRY BALOK |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479131113 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HULKA FALLOPIAN TUBE CLIP |
| Generic Name | TALLOPIAN TUBE CLIP |
| Product Code | HGB |
| Date Received | 2004-02-11 |
| Model Number | 4986.09 |
| Catalog Number | 5986.09 |
| Lot Number | 1320 |
| ID Number | NA |
| Device Expiration Date | 2005-06-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 514784 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUM. |
| Manufacturer Address | 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US |
| Baseline Brand Name | HULKA FALLOPIAN TUBE CLIP |
| Baseline Generic Name | FALLOPIAN TUBE CLIP |
| Baseline Model No | 4986.09 |
| Baseline Catalog No | 4986.09 |
| Baseline ID | 1220 |
| Baseline Device Family | TUBAL OCCLUSION CLIP |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | Y |
| Premarket Approval | P8700 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-11 |