MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-11-07 for OB PACK SMA12OBFHB manufactured by Allegiance Healthcare.
[102197]
The infant was less than 3 hrs old. The surgeon had clamped and cut the umbilical cord the infant was then passed to the mother to see her infant. The nurse took the infant approx 4 feet to the infant warmer for add'l cleaning and routine. The rn turned to complete the infants chart and upon returning to the infant noticed bleeding through the infants wrap. Upon examination it was noticed that the cord clamp had opened partially and fell off. A kelly clamp was placed on the umbilical cord until another cord clamp was obtained and placed on the infant. No add'l med treatment was done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-1997-00229 |
| MDR Report Key | 130696 |
| Report Source | 05 |
| Date Received | 1997-11-07 |
| Date of Report | 1997-11-07 |
| Date of Event | 1997-10-19 |
| Date Mfgr Received | 1997-10-21 |
| Date Added to Maude | 1997-11-12 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | OB PACK |
| Generic Name | OB PACK |
| Product Code | MLS |
| Date Received | 1997-11-07 |
| Model Number | SMA12OBFHB |
| Catalog Number | SMA12OBFHB |
| Lot Number | 279226 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 127814 |
| Manufacturer | ALLEGIANCE HEALTHCARE |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | OB PACK |
| Baseline Generic Name | OB PACK |
| Baseline Model No | SMA12OBFHB |
| Baseline Catalog No | SMA12OBFHB |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-11-07 |