MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-09 for DELEE MUCUS TRAP 8888 manufactured by Sherwood Medical.
[9711]
Mucus trap was used on a newborn by respiratory therapy. A total of 3 traps were used and each time the trap allowed the meconium stained fluid to pass through the filter and enter the suction tube and into the mouth of the therapist. The therapist since has begun his hepatitis b immunization series. These traps are to be for mouth and wall suction and also hydrophobic filter. This episode was reported to the co and several traps were sent to them for further testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001008 |
| MDR Report Key | 11908 |
| Date Received | 1994-03-09 |
| Date of Report | 1994-02-21 |
| Date of Event | 1994-01-29 |
| Date Added to Maude | 1994-03-10 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELEE MUCUS TRAP |
| Product Code | CBC |
| Date Received | 1994-03-09 |
| Catalog Number | 8888 |
| Lot Number | 536017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11908 |
| Manufacturer | SHERWOOD MEDICAL |
| Manufacturer Address | ST. LOUIS MO 63103 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-09 |