MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for COMPRESSION BANDAGE manufactured by Unknown.
[136444546]
I had ankle surgery and had steri-strips and mastisol used on the site. After two weeks intense itching started, everything was removed and wiped with alcohol. There was moderate redness. Cortisone and compression bandages were applied. The following week it turned into a severe, blistered, intensely itchy patch about 4 in wide that lasted for over a month. The alcohol wiping had not removed it entirely and instead pushed it around, leaving red marks in the shape of the wiping at the edges of the patch. Other serious/important medical incidents: extreme allergic dermatitis. How was it taken or used? Topical. Therapy duration: 2 weeks. Why was the person using the product? Surgical site adhesive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083864 |
| MDR Report Key | 8325328 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-12-18 |
| Date Added to Maude | 2019-02-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | COMPRESSION BANDAGE |
| Generic Name | COMPRESSION BANDAGE |
| Product Code | MHW |
| Date Received | 2019-02-08 |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Brand Name | MASTISOL |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2019-02-08 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FERNDALE LABORATORIES, INC |
| Brand Name | STERI-STRIPS |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2019-02-08 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-08 |