MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-11 for COBAN 2 LAYER COMPRESSION SYSTEM 2094 manufactured by 3m Health Care.
[38034421]
No information supplied by reporter. Date of event: no information supplied by reporter.
Patient Sequence No: 1, Text Type: N, H10
[38034422]
Customer reported an inpatient was seen by vascular and coban 2 layer lite compression system was recommended for his care. Coban 2 layer lite was used while the patient was in the hospital. When transferring the patient to the community, the referral stated coban 2 layer compression system instead of coban 2 layer lite compression system. The community ordered coban 2 layer compression system for this patient's care. The patient subsequently developed a suspected deep tissue injury (sdti) to his heel which was later classified as grade 3. No additional information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2016-00014 |
| MDR Report Key | 5430980 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-11 |
| Date of Report | 2016-01-14 |
| Date Mfgr Received | 2016-01-14 |
| Date Added to Maude | 2016-02-11 |
| 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 KAREN KRENIK, BSN |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517333091 |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH, WERK |
| Manufacturer Street | MANUFACTURING MEDICAL DEVICES EDISONSTRASSE 6 |
| Manufacturer City | KAMEN, 59174 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 59174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAN 2 LAYER COMPRESSION SYSTEM |
| Generic Name | COBAN 2 LAYER COMPRESSION SYSTEM |
| Product Code | FQM |
| Date Received | 2016-02-11 |
| Catalog Number | 2094 |
| 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 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-11 |