MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-15 for APTIMA SWAB SPECIMEN COLLECTION KIT 301041-01 manufactured by Hologic, Inc..
[28449775]
A customer found an improvised cutting device contained in one of the collection pouches in an aptima swab collection kit, p/n 301041-01, l/n 108901. Thermoformer operators are required to cut paper and plastic rolls and this device must have been used by an operator for this purpose. This device must have accidently fell into a pouch during the manufacturing process. There have been no further complaints by customers for this lot of collection kits. This investigation concludes that it is highly unlikely that any more of these devices are in pouches from this batch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2015-00004 |
| MDR Report Key | 5154616 |
| Date Received | 2015-10-15 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-09-23 |
| Date Mfgr Received | 2015-09-23 |
| Date Added to Maude | 2015-10-15 |
| 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 | RON DOMINGO |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108167 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APTIMA SWAB SPECIMEN COLLECTION KIT |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2015-10-15 |
| Model Number | 301041-01 |
| Catalog Number | 301041-01 |
| Lot Number | 108901A |
| Device Availability | Y |
| 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 | 2015-10-15 |