FDA Adverse Event
Injury
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2062637
·
Received April 8, 2011
Report
- Report Number
- 3004753838-2011-00089
- Event Type
- Injury
- Date Received
- April 8, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 16, 2011
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P050012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HE EXPERIENCED A SEVERE RASH AND BLISTERING DUE TO THE SENSOR ADHESIVE. PATIENT CONSULTED HIS ENDOCRINOLOGIST, WHO GAVE HIM VARIOUS BARRIER TAPES. IN A FOLLOW-UP CALL MADE BY DEXCOM TECHNICAL SUPPORT, PATIENT REPORTED THAT THE AFFECTED SITE WAS HEALING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |