MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-30 for BINKY-GRIPTIGHT * UNK manufactured by Binky-griptight, Inc..
[57580]
Mother of baby found pacifier in baby's crib in two pieces. The "button" handle had separated from the main body of the pacifier. This pacifier was obtained at hospital and was less than 2 months old. The "button" when separated from the pacifier, presents a choking hazard. As a safety precaution, all "binky-griptight" pacifiers are being removed from stock at butterworth hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 102502 |
| MDR Report Key | 102502 |
| Date Received | 1997-06-30 |
| Date of Report | 1997-05-09 |
| Date of Event | 1997-05-07 |
| Date Facility Aware | 1997-05-07 |
| Report Date | 1997-05-09 |
| Date Reported to Mfgr | 1997-05-09 |
| Date Added to Maude | 1997-07-07 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BINKY-GRIPTIGHT |
| Generic Name | PACIFIER, LATEX NIPPLE |
| Product Code | MEF |
| Date Received | 1997-06-30 |
| Model Number | * |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 42 DAY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 100876 |
| Manufacturer | BINKY-GRIPTIGHT, INC. |
| Manufacturer Address | * WALLINGTON NJ 070573307 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1997-06-30 |