MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-23 for COBAN 2 LITE LAYER COMPRESSION SYSTEM 20721 manufactured by 3m Health Care.
[184779164]
Date of event was reported as (b)(6) 2019- exact date not provided, so estimated date entered as the (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[186507929]
Patient information was not supplied by reporter. Date of event was reported as (b)(6) 2020 - exact date not provided, so estimated date entered as the (b)(6) of the month. The 3m coban 2 lite layer compression system was reported by the consumer to have been worn for an extended period of time before the system was removed and another was placed. The instructions for use for 3m coban 2 lite layer compression system includes in the product description that the system and its components are intended for single use and may be worn up to seven days. General consideration and warnings that wrapping too tightly may impair circulation. Monitor the area of application frequently for signs of discoloration, pain, numbness, tingling or other changes in sensation and swelling. If these symptoms occur, patients should be advised to remove coban 2 (lite) compression system and promptly contact their health care provider. 3m will continue to monitor complaints and trends for this type of report.
Patient Sequence No: 1, Text Type: N, H10
[186507930]
A consumer reported right foot discoloration, tingling and numbness, and enlargement of an ulcer on the ankle and compression of the right leg while using 3m? Coban? 2 lite compression system for leg swelling. Use of coban 2 lite compression system began in (b)(6) 2019, applied over a silver antimicrobial foam dressing for an ankle ulcer. Coban 2 lite compression system was worn for about two months before it was changed, followed by weekly changes thereafter. The ulcer reduced in size during weekly changes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00017 |
| MDR Report Key | 9869125 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 AVENUE SOUTH |
| Manufacturer City | BROOKINGS, SD |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAN 2 LITE LAYER COMPRESSION SYSTEM |
| Generic Name | COBAN 2 LITE LAYER COMPRESSION SYSTEM |
| Product Code | FQM |
| Date Received | 2020-03-23 |
| Catalog Number | 20721 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other; 2. Required No Informationntervention | 2020-03-23 |