MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-10-20 for LABOR & DELIVERY PACK SMA48OBIMA manufactured by Allegiance Healthcare Corp..
[193880]
It has ben reported that on two separete occasions a nursery room nurse noticed blood on the infants receiving blanket. Upon opening the blankets one cord clamp was found to be off half way and the other showed signs of slippage. One infant they estimated 5cc loss of blood and physician ordered an additional hemoglobin test. Both infants were fine and released. No additonal medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1999-00304 |
| MDR Report Key | 245513 |
| Report Source | 05 |
| Date Received | 1999-10-20 |
| Date of Report | 1999-10-20 |
| Date of Event | 1999-09-12 |
| Date Mfgr Received | 1999-09-22 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 1999-10-22 |
| 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 | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8477853309 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LABOR & DELIVERY PACK |
| Generic Name | LABOR & DELIVERY PACK |
| Product Code | MLS |
| Date Received | 1999-10-20 |
| Model Number | SMA48OBIMA |
| Catalog Number | SMA48OBIMA |
| Lot Number | 253976 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 237864 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Baseline Brand Name | LABOR & DELIVERY PACK |
| Baseline Generic Name | LABOR & DELIVERY PACK |
| Baseline Model No | SMA48OBIMA |
| Baseline Catalog No | SMA48OBIMA |
| Baseline ID | NA |
| Baseline Device Family | DELIVERY PACK |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K810242 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-10-20 |