MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-05-18 for APTIMA SPECIMEN COLLECTION DEVICE 301041-01 manufactured by Hologic, Inc..
[75454023]
Hologic followed up several times with reporter but no information was available if and where this issue actually occurred.
Patient Sequence No: 1, Text Type: N, H10
[75454024]
Hologic received an email notification from (b)(6) on 21apr2017 who received an email from (b)(6), a lead nurse at (b)(6) (b)(6) indicating that there was reports of bowel perforation when using the purple aptima (b)(6) swabs. According to the email communication, the incident did not occur at the (b)(6) site but at another unknown clinic. The reported information stated that customer used the aptima unisex swab specimen collection kit off package insert (pi) instructions by taking rectal samples. The customer acknowledges the use is off pi instructions and has reminded their team not to use these tubes. Hologic followed up with (b)(6) teaching hospitals to get more information on the reported incident(s) but as the incident had not occurred at their hospital, they have no further details and could not confirm the occurrence or location of this incident. There have been no other reports of this nature to hologic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00014 |
| MDR Report Key | 6575650 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-05-18 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-04-21 |
| Date Added to Maude | 2017-05-18 |
| 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 | MS JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| 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 SPECIMEN COLLECTION DEVICE |
| Generic Name | IN-VITRO DIAGNOSTICS |
| Product Code | LSL |
| Date Received | 2017-05-18 |
| Catalog Number | 301041-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2017-05-18 |