MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2010-06-28 for K-Y TOUCH MASSAGE 2 IN 1 WARMING KY21WMUS manufactured by J & J Healthcare Products.
[2716087]
Consumer's mother reports (b)(6) son admitted to emergency room with allergic reaction. Consumer suffered a severe allergic reaction (anaphylaxis) after application of the product to body. It is unknown if the consumer has any previous allergies. The application of the product to the whole body may have contributed to the severity of the reaction leading to his hospital admission. Disorientation, confusion and dizziness can occur in anaphylactic reactions and is not unexpected. The introduction of a saline drip is standard procedure to help prevent shock. The lack of effect by the phenergan antihistamine is also not unexpected as anaphylaxis can be difficult to manage.
Patient Sequence No: 1, Text Type: D, B5
[9888346]
This event is from a consumer in australia. The product was discontinued in 2008, so it is highly probably the product used was past its expiry date. Date of this submission is (b)(4) 2010. This closes out this report unless additional significant info is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2010-00007 |
| MDR Report Key | 2581192 |
| Report Source | 01,04 |
| Date Received | 2010-06-28 |
| Date of Report | 2010-06-21 |
| Date Mfgr Received | 2010-06-21 |
| Date Added to Maude | 2012-05-23 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY REGULSKI |
| Manufacturer Street | 199 GRANDVIEW RD. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089043329 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y TOUCH MASSAGE 2 IN 1 WARMING |
| Generic Name | PERSONAL LUBRICAN + MASSAGE |
| Product Code | MMS |
| Date Received | 2010-06-28 |
| Model Number | KY21WMUS |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J & J HEALTHCARE PRODUCTS |
| Manufacturer Address | 199 GRANDVIEW RD. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-06-28 |