MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-10 for TEMPA-DOT * manufactured by Pymah Corp..
[92147]
Rptr is assistant director at blood bank, rptr was auditing the blood bank, and when they were inspecting donor's area they found they were using an product to measure temperature called tempa-dot. As soon as rptr found this product they concluded it was expired. They closed that area until they are able to get more info. The product box had a different label: exp as expedition date and val as valid date. Rptr tried to call the pymatt corp in somerville nj, to get more info about the lot number and to clarify, but the phone number had changed. Rptr does not know for sure if "exp" is for expiration or expedition date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002018 |
| MDR Report Key | 125996 |
| Date Received | 1997-10-10 |
| Date of Report | 1997-10-10 |
| Date Added to Maude | 1997-10-16 |
| 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 | TEMPA-DOT |
| Generic Name | COLOR CHANGE THERMOMETER |
| Product Code | FQZ |
| Date Received | 1997-10-10 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | C234A |
| ID Number | * |
| Device Expiration Date | 1996-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 123321 |
| Manufacturer | PYMAH CORP. |
| Manufacturer Address | 89 ROUTE 206 PO BOX 1114 SOMERVILLE NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-10 |