MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-19 for TYVEK? POUCH WITH STERRAD? CHEMICAL INDICATOR 12320 manufactured by Advanced Sterilization Products.
[95316418]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[95316419]
A customer reported a female health care worker (hcw) experienced a second degree chemical burn on her right hand thumb when she touched a tyvek? Self-seal pouch that had been processed in three consecutive sterrad? 100nx cycles. The hcw was wearing gloves when she initially removed the tyvek? Self-seal pouch from the sterilizer and placed the tyvek? Self-seal pouch on a rack prior to putting it away. She later removed her gloves and picked up the same tyvek? Self-seal pouch to put it away, and then experienced a burn on her right thumb. She washed the affected area and the skin started to? Bubble like a blister?. The hcw was treated in the emergency room with bacitracin ointment, vaseline gauze and a kling dressing. She also received follow-up at a burn center, where she continued with the same topical treatment and was instructed not to lift anything. The affected area measured a little bit bigger than the size of a quarter, and the white area peeled off in approximately five days. The hcw reported the skin completely healed, but is still very sensitive to touch. The topical treatment was discontinued and the hcw returned to work on (b)(6) 2017 and at that time she said she was doing? Fine. " service was not dispatched for the sterrad? 100nx since the customer acknowledged user error as the cause of the h2o2 reaction. The hcw stated they had incorrectly placed the tyvek? Self-seal pouch on the top shelf of the chamber making it difficult to see which lead to them leaving it in for two additional cycles. She stated she did not notice any abnormalities when removing the tyvek? Self-seal pouch from the unit nor did she notice any residual h2o2 on the tyvek? Self-seal pouch when she touched it. The customer was advised to always wear personal protective equipment (ppe) when handling any processed items. Based on the information contained in the complaint at the time the reporting determination was made, this complaint is deemed reportable as a serious injury. The hcw experienced a second degree burn and received medical treatment. Although there were no reported product malfunctions, this event was related to? User error? Which resulted in a serious injury. This is two of two 3500a reports being submitted for this serious injury involving two asp products. Please reference manufacturer report numbers: 2084725-2017-00679 & 2084725-2017-00680
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2017-00680 |
| MDR Report Key | 7132226 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-19 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2017-12-19 |
| 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 Contact | MR. JOAQUIN KURZ |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | ASP IRVINE MFG |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYVEK? POUCH WITH STERRAD? CHEMICAL INDICATOR |
| Generic Name | SELF-SEAL POUCH |
| Product Code | JOJ |
| Date Received | 2017-12-19 |
| Catalog Number | 12320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-19 |