MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-03 for AC2, 250T AMPLIFICATION REAGENT 301130 manufactured by Hologic Incorporated.
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(b)(6), the customer called to report she cut herself on the glass of the amplification bottle. The bottom of vial was broken and there were shards of glass in the box. She did not know the vial was broken so when she went to pick up the bottle a pin size piece of glass penetrated her glove and cut her left middle finger. Medical treatment: per their lab protocol: (b)(6) took off gloves, wiped injured finger with alcohol and washed area with soap and water. Per hospital protocol, she got a tetanus shot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2016-00021 |
| MDR Report Key | 5995444 |
| Date Received | 2016-10-03 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-09-06 |
| Device Manufacturer Date | 2016-07-12 |
| Date Added to Maude | 2016-10-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DR |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC |
| Manufacturer Street | 10210 GENETIC CENTER DR |
| 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 | 0 |
| Brand Name | AC2, 250T AMPLIFICATION REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LSL |
| Date Received | 2016-10-03 |
| Catalog Number | 301130 |
| Lot Number | 174194DH |
| Device Expiration Date | 2017-11-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-03 |