MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-09-08 for MAMMOSITE OFFICE ACCESSORY KIT UNKNOWN manufactured by Adi Medical.
[85447366]
This is an oem glove from adi medical and is not a hologic product and we are in contact with the supplier to notify them of this issue. Reference internal complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[85447367]
It was reported by the patient's husband the physician performed a mammosite radiation breast procedure (exact date unknown) on his wife. The patient was discharged home. The husband reported "when he put the gloves on which were only on for about 15 minutes each time his hands sweat badly. The 4th time he put the gloves on his hands sweat so badly his skin peeled off when he took the gloves off. His hands have scabbed over and he is fine now". On (b)(6) 2017, the husband reported his skin started to peel and he used the antiseptic ((b)(6) ) and band-aids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00220 |
| MDR Report Key | 6853010 |
| Report Source | OTHER |
| Date Received | 2017-09-08 |
| Date of Report | 2017-08-11 |
| Date Mfgr Received | 2017-08-11 |
| Date Added to Maude | 2017-09-08 |
| 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. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAMMOSITE OFFICE ACCESSORY KIT |
| Generic Name | RADIATION THERAPY SYSTEM KIT |
| Product Code | LRP |
| Date Received | 2017-09-08 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADI MEDICAL |
| Manufacturer Address | 1565 SOUTH SHIELDS DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-09-08 |