MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-07 for OBSTIHOOK * OBS-100 manufactured by Innovative Medical Products, Llc.
[646687]
At delivery baby was noted to have three scratch marks on the right cheek. Mother had artificial rupture of membranes by her ob with the obstihook amniotic membrane perforator prior to delivery. No internal monitors were used. Delivery was easy. Cause of scratch marks is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 876853 |
| MDR Report Key | 876853 |
| Date Received | 2007-06-07 |
| Date of Report | 2007-06-07 |
| Date of Event | 2007-04-27 |
| Report Date | 2007-06-07 |
| Date Reported to FDA | 2007-06-07 |
| Date Added to Maude | 2007-07-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBSTIHOOK |
| Generic Name | AMNIOTIC MEMBRANE PERFORATOR |
| Product Code | HGE |
| Date Received | 2007-06-07 |
| Model Number | * |
| Catalog Number | OBS-100 |
| Lot Number | 1033 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 856184 |
| Manufacturer | INNOVATIVE MEDICAL PRODUCTS, LLC |
| Manufacturer Address | 2515 THREE MILE RD. NW GRAND RAPIDS MI 495341313 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-07 |