MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-06-15 for WOODSON ELEVATOR & SPATULADBL-END254MM MD605 manufactured by Contract Manufacturer: Merced Medical.
[77731969]
Manufacturing site evaluation: evaluation on-going. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[77731970]
Country of complaint: usa. It was reported that the tip broke off the device and fell into the patient. The tip was retrieved from the patient. No x-ray was needed to retrieve tip. No harm to the patient was reported. There was a fifteen minute delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
[96153882]
Manufacturing site evaluation: evaluation on-going. Correction submitted: "an x-ray was needed to recover the broken tip". "the broken tip was found on the floor". Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[96153883]
Country of complaint: usa. It was reported that the tip broke off the device and fell into the patient. The tip was retrieved from the patient. An x-ray was needed to retrieve tip. Tip was found on the floor. No harm to the patient was reported. There was a fifteen minute delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2017-00008 |
| MDR Report Key | 6645172 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-06-15 |
| Date of Report | 2017-07-05 |
| Date of Event | 2017-05-22 |
| Date Facility Aware | 2017-06-14 |
| Date Mfgr Received | 2017-06-30 |
| Date Added to Maude | 2017-06-15 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | CONTRACT MANUFACTURER: MERCED MEDICAL |
| Manufacturer Street | 36131 N. HAZELWOOD DR. |
| Manufacturer City | INGELSIDE IL 60041 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WOODSON ELEVATOR & SPATULADBL-END254MM |
| Generic Name | MICRO NEUROSURGICAL INSTR. / D |
| Product Code | GEG |
| Date Received | 2017-06-15 |
| Model Number | MD605 |
| Catalog Number | MD605 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONTRACT MANUFACTURER: MERCED MEDICAL |
| Manufacturer Address | 36131 N. HAZELWOOD DR. INGELSIDE IL 60041 US 60041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-15 |