MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-19 for 3M? COMPLY? STERIGAGE? 1243A manufactured by 3m Health Care.
| Report Number | 2110898-2019-00095 |
| MDR Report Key | 8906604 |
| Date Received | 2019-08-19 |
| Date of Report | 2019-08-28 |
| Date of Event | 2019-06-21 |
| Date Mfgr Received | 2019-07-23 |
| Date Added to Maude | 2019-08-19 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANNE GIBBS |
| Manufacturer Street | 2510 CONWAY AVE 3M CENTER BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M COMPANY FLEMINGTON PLANT |
| Manufacturer Street | 500 US-202 |
| Manufacturer City | FLEMINGTON NJ 08822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08822 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3M? COMPLY? STERIGAGE? |
| Generic Name | INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS |
| Product Code | JOJ |
| Date Received | 2019-08-19 |
| Catalog Number | 1243A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-19 |