MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-24 for ACE? SELF-ADHERING ELASTIC BANDAGE N/A 207460 manufactured by 3m Health Care.
[142923372]
Initial reporter's occupation is unknown. Product lot # was not provided therefore manufacturing date is unknown. The device was not returned for evaluation. The consumer discarded the product after use. Product lot # is unknown. Without this information, root cause cannot be determined. Product packaging indicates: if any skin irritation occurs, discontinue use and consult a physician. Complaint history was reviewed over the past 24 months for the product's global sales code of tba and the reported failure. No trends were observed. 3m will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[142923373]
A (b)(6)-year-old caucasian, female consumer applied the referenced product to her left knee on (b)(6) 2019. The elastic bandage was worn while snowshoeing and napping. The product was worn for approximately 12 hours and then removed. The consumer alleged she discovered her skin underneath the bandage had a red, raised rash the next day. She reported the rash was very itchy and painful to the touch. The consumer reported her right knee also had a rash present, though less severe. The consumer indicated the right knee rash may have been caused by her knees touching while napping. The consumer reported she had experienced reactions to adhesives in the past. No known allergies were specified. The consumer visited a pa and was prescribed betamethasone 1% along with oral cortisone tablets. The consumer also took benadryl for symptoms. The reported symptoms completely resolved within 7 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00056 |
| MDR Report Key | 8544931 |
| Report Source | CONSUMER |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-04-24 |
| 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 | MR. BRYAN BECKER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517375578 |
| Manufacturer G1 | 3M EDUMEX, S.A. DE C.V. |
| Manufacturer Street | 6620 ORIENTE CALLE RAMON RIVERA LARA |
| Manufacturer City | CD. JUAREZ CHIHUAHUA, 32605 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACE? SELF-ADHERING ELASTIC BANDAGE |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2019-04-24 |
| Model Number | N/A |
| Catalog Number | 207460 |
| Lot Number | UNK |
| 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 AVENUE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-04-24 |