FDA Adverse Event
Injury
Summary report: N
SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L
MDR report key: 2081258
·
Received April 26, 2011
Report
- Report Number
- 2032227-2011-01050
- Event Type
- Injury
- Date Received
- April 26, 2011
- Date of Event
- April 13, 2011
- Report Date
- April 13, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- 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
IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AFTER INSERTING A SENSOR AND EXPERIENCING SWELLING AT THE INSERTION SITE. THE SITE WAS ALSO BLEEDING. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L | GLUCOSE SENSOR (PRODUCT CODE MDS) | MDS | MEDTRONIC MINIMED | MMT-7002C | J140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |