MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for STERI-STRIP R1547 manufactured by 3m Company.
[112012813]
Patient Sequence No: 1, Text Type: N, H10
[112012814]
Sterility issue; opened a pack of steri-strips to the surgical field, the steri-stips had a hair made into the plastic backing of the steri strips. Removed from the sterile field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7629056 |
| MDR Report Key | 7629056 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-06-14 |
| Report Date | 2018-06-18 |
| Date Reported to FDA | 2018-06-18 |
| Date Reported to Mfgr | 2018-06-18 |
| Date Added to Maude | 2018-06-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | STERI-STRIP |
| Generic Name | STRIP, ADHESIVE, CLOSURE, SKIN |
| Product Code | FPX |
| Date Received | 2018-06-22 |
| Catalog Number | R1547 |
| Lot Number | 2023-03AA |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-22 |