MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-02 for * UNK manufactured by Pond(india) Ltd..
[19141417]
Distributor was informed through insurance carrier of retailer from whom the consumer purchased the thermometer, and to whom the consumer registered the complaint, that when the consumer removed the thermometer from its package, the "head" was broken off and mercury spilled out onto jewelry and other nearby items. No injuries were reported. This report is submitted by co based on info received which co may not have had an opportunity to investigate or verify prior to submission of this report. This report shall not be construed as an admission by co (a) that the product described herein was mfg, imported or distributed by co; (b) that any causal relationship exists between such product and any actual or potential injury; or (c) that any reportable event has occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1933255-1997-00005 |
| MDR Report Key | 88800 |
| Date Received | 1997-05-02 |
| Date of Report | 1997-05-02 |
| Date of Event | 1997-03-03 |
| Date Facility Aware | 1997-03-07 |
| Report Date | 1997-05-02 |
| Date Reported to FDA | 1997-05-02 |
| Date Reported to Mfgr | 1997-05-05 |
| Date Added to Maude | 1997-05-07 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | BASAL THERMOMETER |
| Product Code | FLK |
| Date Received | 1997-05-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 87819 |
| Manufacturer | POND(INDIA) LTD. |
| Manufacturer Address | * * IN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-02 |