MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-11 for PEGGY PREEMIE UNK manufactured by Laerdal Medical Corp..
[98286]
Additional info received from mfr on 07/28/1998: mfr has contacted the rptr about the report as laerdal does not have a manikin named peggy preemie. Rptr apologized and informed mfr that they had made a mistake in identifying the mfr on their report. The peggy preemie is a simulaids product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013948 |
| MDR Report Key | 171927 |
| Date Received | 1998-06-11 |
| Date of Report | 1998-06-11 |
| Date of Event | 1998-05-27 |
| Date Added to Maude | 1998-06-12 |
| 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 |
| 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 | PEGGY PREEMIE |
| Generic Name | CPR MANIKIN |
| Product Code | LYM |
| Date Received | 1998-06-11 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 167191 |
| Manufacturer | LAERDAL MEDICAL CORP. |
| Manufacturer Address | 167 MYERS CORNERS RD. WAPPINGER FALLS NY 12590 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-06-11 |