MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-25 for ALIGEL OR OVERLAY PAD 95-365 manufactured by Alimed, Inc..
[73619524]
Patient Sequence No: 1, Text Type: N, H10
[73619525]
Began using a new gel pad in the operating room about 8-9 months ago. After bringing this product in, one associate has experienced several asthma attacks while caring for a patient using this product. It was discovered about two weeks ago that this was the product triggering the attacks. Per the (b)(6), she was opening new gel pads and the smell of them was very strong. The nurse who had been suffering the asthma attacks, started with another attack right away. Another associate in the area who does not suffer from asthma also began to immediately start coughing. That associate was fine when she left the area, the first associate required treatment from occupational health. According the director, the smell eventually lessens over time after multiple cleanings. The thought is that the odor is getting trapped under the drapes and when they go to remove them, they are taking in a concentrated amount of the odor which is what was triggering the asthma attacks. Gel pad indicates it is made of akton, viscoelastic, and polymer. It indicates that it is latex and plasticizer free.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6519169 |
| MDR Report Key | 6519169 |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-07 |
| Date of Event | 2017-03-28 |
| Report Date | 2017-04-07 |
| Date Reported to FDA | 2017-04-07 |
| Date Reported to Mfgr | 2017-04-07 |
| Date Added to Maude | 2017-04-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALIGEL OR OVERLAY PAD |
| Generic Name | SURGICAL TABLE CUSHION |
| Product Code | CCX |
| Date Received | 2017-04-25 |
| Catalog Number | 95-365 |
| ID Number | KBB95-365 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ALIMED, INC. |
| Manufacturer Address | 297 HIGH ST. DEDHAM MA 02026 US 02026 |
| Brand Name | ALIGEL OR OVERLAY PAD |
| Generic Name | SURGICAL TABLE CUSHION |
| Product Code | LWG |
| Date Received | 2017-04-25 |
| Catalog Number | 95-365 |
| ID Number | KBB95-365 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIMED, INC. |
| Manufacturer Address | 297 HIGH ST. DEDHAM MA 02026 US 02026 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-25 |