MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-09-06 for THE TUCKER SLING UNK manufactured by Tucker Designs, Ltd.
[216870]
Death occurred while infant was sleeping in prone position using the tucker sling, an infant positioning/holder device, which was being used with a wedge in a standard sized crib. Infant was positioned in accordance with instructions accompanying the tucker sling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022758 |
| MDR Report Key | 349965 |
| Date Received | 2001-09-06 |
| Date of Report | 2001-08-31 |
| Date of Event | 2000-09-21 |
| Date Added to Maude | 2001-09-06 |
| 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 | THE TUCKER SLING |
| Generic Name | HOLDER/INFANT POSITIONING DEVICE |
| Product Code | FRP |
| Date Received | 2001-09-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | FDA REG #2319127 PAT#4,989,286 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 339273 |
| Manufacturer | TUCKER DESIGNS, LTD |
| Manufacturer Address | PO BOX 64117 KENNER LA 70064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2001-09-06 |