MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for FORCEP ROCH-PEAN CLAMP, DISPOSABLE MAYO CLAMP 09-1360B manufactured by Cardinal Health 200 Llc.
[135722534]
?during repair of vaginal delivery, roch-pean clamp ?popped off ?. md states ?had the clamp been placed on the fetal side of the umbilical cord instead of the maternal side of the umbilical cord the baby could have bled to death ?. md requesting for radar to be written and fda report on device failure to be made .?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083703 |
| MDR Report Key | 8306520 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-31 |
| Date Added to Maude | 2019-02-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FORCEP ROCH-PEAN CLAMP, DISPOSABLE MAYO CLAMP |
| Generic Name | FORCEPS, GENERAL AND PLASTIC SURGERY |
| Product Code | GEN |
| Date Received | 2019-02-04 |
| Catalog Number | 09-1360B |
| Lot Number | 113628 (LIKE ITEM, ACT DISPOSE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200 LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-04 |