MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-15 for LOVE-GRUENWALD PITUITARY FCPS NL6146 manufactured by Cardinal Health.
[605650]
The physician was doing a lumbar laminectomy when the tip broke off and fell in the patient's back. Additionally, account stated the physician was doing a lumbar laminectomy when the tip broke off and fell in the patient's incision. The physician was not able to retrieve the broken tip so it was left in the patients' back. According to the account, the patient is doing okay. The device has been retained by the hospital and will not be released for investigation.
Patient Sequence No: 1, Text Type: D, B5
[7927464]
An investigation was initiated into the matter of, "broken tip" during lumbar laminectomy. The device was not available for evaluation, but the lot number was provided. No issues for the reported lot number were discovered during the device history review. No trend has been detected for this issue. Without instrument, cause for failure could not be determined or the issue confirmed. If the product is returned in the future, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2007-00011 |
| MDR Report Key | 834982 |
| Report Source | 05 |
| Date Received | 2007-02-15 |
| Date of Report | 2007-02-14 |
| Date Mfgr Received | 2007-01-22 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2007-04-09 |
| 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 | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | V-MUELLER-MCGAW PARK |
| Manufacturer City | MCGAW PARK IL * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOVE-GRUENWALD PITUITARY FCPS |
| Generic Name | FORCEPS |
| Product Code | EMH |
| Date Received | 2007-02-15 |
| Model Number | NL6146 |
| Catalog Number | NL6146 |
| Lot Number | C |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 822305 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-15 |