MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-23 for CLINITEST REAGENT 2128 * manufactured by Bayer Diagnostics.
[17905507]
The complainant is a pharmacist that is calling on the behalf of a pt who may have ingested a clinitest tablet. The pharmacist indicated that a customer was admitted to a hospital because pt injected some type of table that exploded as they swallowed it. The customer is a diabetic but it is unknown if they even had clinitest present in their home. No other information is available and the complaint is considered closed for purposes of mdr. If more informaiton becomes available a follow-up report will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1810909-2001-00006 |
| MDR Report Key | 314299 |
| Date Received | 2001-01-23 |
| Date of Report | 2001-01-19 |
| Date of Event | 2000-09-13 |
| Date Added to Maude | 2001-02-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GEORGE TANCOS |
| Manufacturer Street | 1884 MILES AVENUE |
| Manufacturer City | ELKHART IN 46515 |
| Manufacturer Country | US |
| Manufacturer Postal | 46515 |
| Manufacturer Phone | 2192626928 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEST REAGENT |
| Generic Name | TEST FOR SUGAR IN URINE |
| Product Code | JIM |
| Date Received | 2001-01-23 |
| Model Number | 2128 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 303968 |
| Manufacturer | BAYER DIAGNOSTICS |
| Manufacturer Address | WESTERN AVENUE BRIDGEND INDUSTRIAL ESTATE BRIDGEND, WALES WS |
| Baseline Brand Name | CLINITEST |
| Baseline Model No | 2128 |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2001-01-23 |