D
Patient 1
OWEN MUMFORD INC WAS CONTACTED ON (B) (6) 2010 BY A GENTLEMAN WHO REPORTED THAT A UNIFINE PENTIP HAD BENT WHEN ADMINISTERING INSULIN AND THAT ANOTHER WAS 'STUCK' IN HIS SKIN AND HAD TO BE REMOVED BY THE ER.
MAUDE MDR 1700779
- MDR report key
- 1700779
- Report number
- 8021764-2010-00003
- Event key
- 0
- Event type
- 3
- Date received
- 2010-05-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- PATTY CRONAN
- Address
- 1755 A WEST OAK COMMONS CT MARIETTA GA 30062 US
- Phone
- 770-770-7709
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNIFINE PENTIPS | UNIFINE | OWEN MUMFORD, LTD | FMI | AN3530 | 0905752 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-05-26 | 0 | 1. H |
Event Narratives#
N
Patient 1
(B) (6) - COMPLAINANT CONTACTED OMI TO REPORT ISSUE AND WAS REQUESTED TO RETURN NEEDLE HUB AND REMAINING PENTIPS IN HIS BOX. MEDICAL QUESTIONNAIRE SENT TO COMPLAINANT. MARCH/APRIL 2010- OMI TRIED TO CONTACT COMPLAINANT SEVERAL TIMES DURING THESE TWO MONTHS BUT COMPLAINANT DID NOT ANSWER TELEPHONE ON ANY OCCASION. ON 29TH APRIL 2010 - LETTER SENT TO COMPLAINANT TOGETHER WITH ANOTHER MEDICAL QUESTIONNAIRE. AGAIN THE COMPLAINANT HAS BEEN ASKED TO COMPLETE QUESTIONNAIRE AND RETURN PENTIPS FOR EVALUATION. AT THE DATE OF THIS REPORT, THE NEEDLE HUB HAS STILL NOT BEEN RETURNED TO OM.