MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-05 for 3M COMPLY STERIGAGE/STERILIZATION INDICATOR 1243 manufactured by 3m Company.
| Report Number | MW5087917 |
| MDR Report Key | 8768317 |
| Date Received | 2019-07-05 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-06-21 |
| Date Added to Maude | 2019-07-08 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3M COMPLY STERIGAGE/STERILIZATION INDICATOR |
| Generic Name | INDICATOR, PHYSICAL/CHEMICAL STERILAZATION PROCESS |
| Product Code | JOJ |
| Date Received | 2019-07-05 |
| Model Number | 1243 |
| Catalog Number | 1243 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-05 |