MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2012-03-21 for STOMAHESIVE PASTE 183910 manufactured by Convatec.
[16004240]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[16126167]
Wife has applied the paste approx 3-4 times to her husbands stoma and on saturday had a severe reaction-anaphylactic shock and was rushed to the hospital. She experienced increase pulse and b/p, swelling of the tongue, tingling of the face, decrease in muscle strength of all extremities. Reaction peaked 2 hours after appliance change. She has multiple chemical sensitivities such as a severe reaction to tartrazine. She has multiple medical conditions. She takes b/p meds. They are looking to find out if this product contains tartrazine as if not she has now developed another allergy. The formulation for the paste does not contain tartrazine. From a clinical perspective, a causal relationship between the stomahesive paste and this severe event is deemed possibly related. It is unk what other medications or products were in use at the time of the event, or if she had any prior experience using this paste. It was reported that she is now back at home. Treatments given are not available, but she is reportedly "doing fine". Although attempted, no additional info has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243969-2012-00022 |
| MDR Report Key | 2507512 |
| Report Source | 01,04,07 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-02-21 |
| Date of Event | 2012-02-18 |
| Date Mfgr Received | 2012-02-21 |
| Date Added to Maude | 2012-08-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOMAHESIVE PASTE |
| Generic Name | PROTECTIVE SKIN BARRIER |
| Product Code | EZR |
| Date Received | 2012-03-21 |
| Model Number | NA |
| Catalog Number | 183910 |
| Lot Number | UNK |
| 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 | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2012-03-21 |