MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for LUIKART-SIMPSON OBSTET FCPS 356MM MB298R manufactured by Merced Medical, Inc..
[121991891]
Manufacturing site evaluation: evaluation on-going. Pending further information.
Patient Sequence No: 1, Text Type: N, H10
[121991892]
It was reported by the healthcare professional to the company sales representative "product was being used during delivery. Drs. Were unable to pull the forceps apart. After a few minutes of manipulation they were able to remove the forceps". No patient injury was reported. Ten to fifteen minutes delay in surgery was reported. No additional intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2018-00029 |
| MDR Report Key | 7915127 |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-09 |
| Date Facility Aware | 2018-08-30 |
| Date Mfgr Received | 2018-08-30 |
| Date Added to Maude | 2018-09-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 Phone | 3145515988 |
| Manufacturer G1 | MERCED MEDICAL, INC. |
| Manufacturer Street | 1013 WEST WISE ROAD SUITE 201 |
| Manufacturer City | SCHAUMBURG 60193 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60193 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LUIKART-SIMPSON OBSTET FCPS 356MM |
| Generic Name | OBSTETRICAL FORCEPS, SPECIAL FORCEP |
| Product Code | HDA |
| Date Received | 2018-09-27 |
| Model Number | MB298R |
| Catalog Number | MB298R |
| Lot Number | 101020SH |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERCED MEDICAL, INC. |
| Manufacturer Address | 1013 WEST WISE ROAD SUITE 201 SCHAUMBURG 60193 US 60193 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-09-27 |