MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for COMPLY? STERIGAGE? manufactured by 3m Company.
[136609295]
Several 3m #1243 comply sterigage steam chemical integrators appeared to have "exploded" in sterilized peal packs, wrapped packs and rigid containers. All collected were of lot number 202311dp and 202311dr. 3m has been notified of the two affected lot numbers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8353500 |
| MDR Report Key | 8353500 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-24 |
| Report Date | 2019-01-29 |
| Date Reported to FDA | 2019-01-29 |
| Date Reported to Mfgr | 2019-02-20 |
| Date Added to Maude | 2019-02-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | COMPLY? STERIGAGE? |
| Generic Name | INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS |
| Product Code | JOJ |
| Date Received | 2019-02-20 |
| Lot Number | 202311DP |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 500 RT. 202 NORTH FLEMINGTON NJ 08822 US 08822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |