MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-05 for K-Y BRAND LUBRICANT JELLY manufactured by Reckitt Benckiser Healthcare Int. Limited.
[76661080]
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident. The patient did not specify the variety of k-y that was used. The patient also did not provide the batch details for the product nor returned any of the remaining unopened product for quality analysis. Therefore, the company is unable to conduct any further investigation at this moment in time. Further information is expected. The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[76661081]
Initial report, received date: 22-may-2017. Received from consumer relations, country: united states, reference no: (b)(4). Suspect product: k-y unspecified. Batch no and expiry date: not provided. Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a female aged (b)(6). It was reported that on an unknown date, a female patient of an unknown age used k-y unspecified, route, indication, stop date and duration were all unknown. She said she was highly allergic. She had been to her ob/gyn (obstetrician and gynecologist). She had a severe reaction and she had to be catheterized. The case was deemed serious. No further information was available at the time of report. Case assessment of k-y unspecified is as follows: the reported serious assessment has not been provided, case relatedness is possible. The company's assessment is serious with a relatedness of possible and unknown. Case outcome: recovered/resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010164364-2017-00005 |
| MDR Report Key | 6611327 |
| Report Source | CONSUMER |
| Date Received | 2017-06-05 |
| Date of Report | 2017-05-22 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-06-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HULL HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer Phone | 4042478 |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HULL HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU8 7DS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y BRAND LUBRICANT JELLY |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2017-06-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Address | DANSOM LANE HULL, HULL HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-05 |