MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-16 for BIOTENE ORAL BALANCE GEL manufactured by Ultradent Products Inc/oratech Llc.
[142209290]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142209291]
I have been experiencing severe rectal bleeding for 2 days and severe cramps as well and the last thing i took was this gel [rectal bleeding]. I have been experiencing severe cramps as well and the last thing i took was this gel [cramp]. Case description: this case was reported by a consumer and described the occurrence of rectal bleeding in a female patient who received glycerin (biotene oral balance gel) gel (batch number unknown, expiry date unknown) for product used for unknown indication. On an unknown date, the patient started biotene oral balance gel. On an unknown date, an unknown time after starting biotene oral balance gel, the patient experienced rectal bleeding (serious criteria gsk medically significant) and cramp. The action taken with biotene oral balance gel was unknown. On an unknown date, the outcome of the rectal bleeding and cramp were unknown. It was unknown if the reporter considered the rectal bleeding and cramp to be related to biotene oral balance gel. Additional information: adverse event information was received on 26 march 2019 via live call. Consumer reported that, "i have been experiencing severe rectal bleeding for 2 days and severe cramps as well and the last thing i took was this gel".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00050 |
| MDR Report Key | 8518576 |
| Report Source | CONSUMER |
| Date Received | 2019-04-16 |
| Date of Report | 2019-03-26 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-16 |
| 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 Street | PO BOX 13398 RESEARCH TRIANGLE PARK |
| Manufacturer City | NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE ORAL BALANCE GEL |
| Generic Name | ORAL GEL |
| Product Code | LFD |
| Date Received | 2019-04-16 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC/ORATECH LLC |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-16 |