MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-08-26 for MOTHER/BABY KIT MC57SJLMBD manufactured by Allegiance Healthcare Corp..
[109390]
Infant was admitted back to the hospital, 3 hours after being sent home, as the thermometer was giving a reading of 102-103. Hospital staff suspected the thermometer, shook it down, and found out it was giving false readings. Both thermometer from kit and their own as well was used to determine the inaccurate reading. Infant was doing fine and released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1998-00273 |
| MDR Report Key | 184169 |
| Report Source | 05 |
| Date Received | 1998-08-26 |
| Date of Report | 1998-08-26 |
| Date of Event | 1998-07-14 |
| Date Mfgr Received | 1998-08-03 |
| Date Added to Maude | 1998-08-28 |
| 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 | MOTHER/BABY KIT |
| Generic Name | MOTHER/BABY KIT |
| Product Code | FLK |
| Date Received | 1998-08-26 |
| Returned To Mfg | 1998-08-13 |
| Model Number | MC57SJLMBD |
| Catalog Number | MC57SJLMBD |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 179043 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | MOTHER/BABY KIT |
| Baseline Generic Name | MOTHER/BABY KIT |
| Baseline Model No | MC57SJLMBD |
| Baseline Catalog No | MC57SJLMBD |
| Baseline ID | NA |
| Baseline Device Family | STANDARD PACK |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-08-26 |