MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2009-03-18 for SOFT CIRCUMCISION STRAP, INFANT 37500 manufactured by Kimberly-clark Corp..
[1079364]
Kimberly-clark received a complaint indicating that a "nursery is having trouble with the circumcision strap not holding "way back". After further inquiry to the user hospital, the product problem is noted to be related to the velcro detaching from the strap release. The user hospital has not reported any injuries related to this product problem. Kimberly-clark has no independent knowledge of the event reported but is relaying the info that was provided by the user facility where the incident occurred. This product incident is documented in the kimberly-clark complaint database.
Patient Sequence No: 1, Text Type: D, B5
[8187624]
Samples from lot number have been received and are being evaluated. Investigation is in-process. Supplemental report will be sent when additional info becomes available. Info from this incident will be included in our product complaint & mdr trend reporting systems. Ongoing analysis of trend info is used to identify the need for additional investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616096-2009-00002 |
| MDR Report Key | 1354585 |
| Report Source | 05,06,08 |
| Date Received | 2009-03-18 |
| Date of Report | 2009-03-16 |
| Date of Event | 2009-02-19 |
| Date Mfgr Received | 2009-02-19 |
| Date Added to Maude | 2009-08-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ADVERSE EVENT COORDINATOR |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD, B200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877200 |
| Manufacturer G1 | KIMBERLY-CLARK CORP. |
| Manufacturer Street | KM 4.5 CARRETERRA PRESA LA AMISTAD |
| Manufacturer City | CIUDAD DE ACUNA, COAHUIL 26200 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 26200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT CIRCUMCISION STRAP, INFANT |
| Generic Name | CIRCUMCISION SET |
| Product Code | OHG |
| Date Received | 2009-03-18 |
| Returned To Mfg | 2009-02-24 |
| Catalog Number | 37500 |
| Lot Number | AM8119874 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORP. |
| Manufacturer Address | CIUDAD DE ACUNA, COAHUIL 26200 MX 26200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-18 |