MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-04-02 for FASTFIX AB 7209398 manufactured by Mansfield Manufacturing Site.
[1197306]
Four devices were used in this case. The first two, the suture broke after t1 was placed. The ts were left in the patient unsupported. The case was completed with the other two fast-fix. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[8459053]
Two devices were returned for evaluation. Sample one no ts or suture remain on the needle. Sample two t2 the remaining suture is present. Ultra fast-fix has been introduced to the market to address suture issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2009-00114 |
| MDR Report Key | 1394815 |
| Report Source | 06 |
| Date Received | 2009-04-02 |
| Date of Report | 2009-03-11 |
| Date of Event | 2009-03-10 |
| Date Facility Aware | 2009-03-10 |
| Report Date | 2009-04-02 |
| Date Mfgr Received | 2009-03-10 |
| Device Manufacturer Date | 2008-08-13 |
| Date Added to Maude | 2009-08-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON BILOBRAM |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491630 |
| Manufacturer G1 | MANSFIELD MANUFACTURING SITE |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FASTFIX AB |
| Generic Name | FASTFIX AB ASSY - STRAIGHT / KGS |
| Product Code | KGS |
| Date Received | 2009-04-02 |
| Returned To Mfg | 2009-03-25 |
| Model Number | 7209398 |
| Catalog Number | 7209398 |
| Lot Number | 50263666 |
| Device Expiration Date | 2013-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MANSFIELD MANUFACTURING SITE |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-02 |