MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for 3M? STERI-DRAPE? LARGE TOWEL DRAPE 1010 manufactured by 3m Health Care.
[186508202]
Patient information was not provided. Without a lot number, the expiration date and manufacture date could not be determined. No sample was received for analysis and no lot number was provided. A 2-year review of historical complaint data showed no trends were observed. 3m will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[186508203]
An anaphylactic reaction was reported that occurred six days after a cervical fusion surgery protected by a 3m? Steri-drape? Large towel drape 1010. A medical alert band was worn the day of surgery due to prior skin reactions with adhesives. The consumer went to the emergency room six days after surgery due to symptoms of facial itchiness with a burning sensation and facial and throat swelling. An intravenous infusion of diphenhydramine and a steroid was administered, and the symptoms resolved. The consumer was discharged from the emergency room the same day. Skin redness under the adhesive area of the 3m? Steri-drape? Large towel drape 1010 was also observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00018 |
| MDR Report Key | 9899124 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-06-16 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7379117 |
| Manufacturer G1 | 3M BROOKINGS |
| Manufacturer Street | 601 22ND AVE SOUTH PO BOX 5227 |
| Manufacturer City | BROOKINGS, SD |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? STERI-DRAPE? LARGE TOWEL DRAPE 1010 |
| Generic Name | DRAPE, SURGICAL |
| Product Code | PUI |
| Date Received | 2020-03-30 |
| Model Number | 1010 |
| Catalog Number | 1010 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-30 |