MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-29 for APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT 301162 manufactured by Hologic, Inc..
[5151770]
Gp having taken normal vaginal swab was transferring to the transport tube and "breaking" the head within the tube rather than breaking in its designed spot, the pink handle broke in two places with a one cm part flying back up with some force into the gp's eye causing distress to her. Main part of the swab sample remained in bottle, main part of stem in hand. The user took steps to irrigate eye in case of local contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2014-00004 |
| MDR Report Key | 4211640 |
| Report Source | 07 |
| Date Received | 2014-10-29 |
| Date of Report | 2014-10-24 |
| Date of Event | 2014-09-25 |
| Date Mfgr Received | 2014-10-03 |
| Device Manufacturer Date | 2014-03-14 |
| Date Added to Maude | 2014-10-30 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RON DOMINGO |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108167 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2014-10-29 |
| Model Number | 301162 |
| Catalog Number | 301162 |
| Lot Number | 108908A |
| Device Expiration Date | 2015-02-28 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-29 |