MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-22 for OBSTETRICAL PACK 29730 manufactured by Allegiance Healthcare.
[16788603]
At delivery, dr attempted to use bulb syringe, present in delivery pack. Bulb syringe did not work properly. New syringe given to dr upon request. Baby had slight respiratory distress post delivery and was suctioned with 6f catheter. In nursery infant 02 saturation 90 then dropped 85-86% - 02 flow by for 2 minutes then gradually withdrawn. 02 saturation remained in the 94-98%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1998-00188 |
| MDR Report Key | 179472 |
| Report Source | 05 |
| Date Received | 1998-07-22 |
| Date of Report | 1998-07-22 |
| Date of Event | 1998-05-02 |
| Date Mfgr Received | 1998-05-18 |
| Date Added to Maude | 1998-07-30 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBSTETRICAL PACK |
| Generic Name | OBSTETRICAL PACK |
| Product Code | MLS |
| Date Received | 1998-07-22 |
| Model Number | 29730 |
| Catalog Number | 29730 |
| Lot Number | 96HFJ019 |
| 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 | 174505 |
| Manufacturer | ALLEGIANCE HEALTHCARE |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | OBSTETRICAL PACK |
| Baseline Generic Name | OBSTETRICAL PACK |
| Baseline Model No | 29730 |
| Baseline Catalog No | 29730 |
| Baseline ID | NA |
| Baseline Device Family | PROCEDURE 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 | 1998-07-22 |