MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-29 for HAWKINS III BLN 243075 manufactured by Medical Device Technologies, Inc..
[17061230]
Customer reported packages were opened. Initial review of the complaint did not determine this was a safety issue or a reportable event. On april 28, 2008 the samples were returned by the customer. We are unable to isolate the problem to the samples involved in the complaint, but we are able to isolate the problem lot to which the samples belong. Based on the returned samples and further investigation results, medical device technologies, inc has decided to implement a field corrective action. Fda notification of action was sent on may 6, 2006.
Patient Sequence No: 1, Text Type: D, B5
[17283697]
The complaint was due to sealing issues isolated to this specific lot number. Recall issued due to possible sterility impact. No adverse event occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036710-2008-00005 |
| MDR Report Key | 1053565 |
| Report Source | 05 |
| Date Received | 2008-05-29 |
| Date of Report | 2008-05-06 |
| Date of Event | 2008-03-31 |
| Date Mfgr Received | 2008-03-31 |
| Date Added to Maude | 2009-05-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRISTINE LIBERACKI |
| Manufacturer Street | 3600 S.W. 47TH AVE. |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer Phone | 3523380440 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWKINS III BLN |
| Generic Name | BREAST LOCALIZATION NEEDLE |
| Product Code | MIJ |
| Date Received | 2008-05-29 |
| Returned To Mfg | 2008-04-28 |
| Catalog Number | 243075 |
| Lot Number | 80281L5V |
| Device Expiration Date | 2013-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEVICE TECHNOLOGIES, INC. |
| Manufacturer Address | 3600 S.W. 47TH AVE. GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-29 |