MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-06 for MAM 521 STERILE 521 manufactured by Tarry Manufacturing.
[16298448]
This defect was recognized prior to delivery to the pt area. Sterile packaging had been perforated on 41 individual packages. User is confident that the product has come in from mfr in this condition. The packaging of each of the 41 units had been perforated; most appeared to have been sliced - as if by a knife. User suspects - but dose not know - that this happened in the mfr's packaging process. Co has notified the mfr. User will ship the defective product to the mfr - probably on 12/2003.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 524749 |
| MDR Report Key | 524749 |
| Date Received | 2004-02-06 |
| Date of Report | 2003-12-01 |
| Date of Event | 2003-12-01 |
| Date Added to Maude | 2004-05-14 |
| 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 | 3 |
| 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 | MAM |
| Generic Name | INFANT PACIFIER |
| Product Code | MEF |
| Date Received | 2004-02-06 |
| Returned To Mfg | 2003-12-04 |
| Model Number | 521 STERILE |
| Catalog Number | 521 |
| Lot Number | 11Z2 |
| ID Number | * |
| Device Expiration Date | 2004-08-29 |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 513877 |
| Manufacturer | TARRY MANUFACTURING |
| Manufacturer Address | 1 MANNIONS LANE * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-06 |